Date
Post Date
march 2021
Event Details
Am 26. Mai 2021 endet die Übergangsfrist für die Medical Device Regulation MDR – Medizinprodukteverordnung (2017/745). Medizinproduktehersteller müssen sich auf wichtige und aufwändige Neuerungen im Kontext von EUDAMED und Registrierung
Event Details
Am 26. Mai 2021 endet die Übergangsfrist für die Medical Device Regulation MDR – Medizinprodukteverordnung (2017/745). Medizinproduktehersteller müssen sich auf wichtige und aufwändige Neuerungen im Kontext von EUDAMED und Registrierung einstellen. Sind Benannte Stellen immer noch ein Nadelöhr? Laut Nando (New Approach Notified and Designated Organisations) Information System sind es aktuell in Deutschland sechs (6) für die MDR und drei (3) für die IVDR… Read more
Time
(Thursday) 4:00 pm - 6:00 pm CET
Location
Online Event
Organizer
april 2021
22apr2:00 pm4:00 pmIVDR Webinar2:00 pm - 4:00 pm CEST

Event Details
By 26th May 2022, new in-vitro medical devices will have to meet the requirements of the IVDR when sold in the European market. This is not just a critical business factor
Event Details
By 26th May 2022, new in-vitro medical devices will have to meet the requirements of the IVDR when sold in the European market.
This is not just a critical business factor but a major roadblock for many companies. To support you best we have partnered with Eurofins Genomicswho have a deep understanding of this situation as many of their customers face the challenge to comply with the new IVD regulation to set up this exclusive IVDR webinar.
Join us on April 22 to this unique (and free) webinar to learn:
✅ Understand key regulatory stakeholders and their expectations
✅ Notified Body – Do’s and don’ts
✅ Technical Documentation – usual methods and best practices
✅ The latest trends in the interpretation of guidance to confirm the right classification and related product families
✅ Applicable standards and regulatory requirements
✅ Documenting the evidence of scientific validity for your IVD (by examples)
✅ And much more!
BONUS: 1h free follow-up consulting by a Medidee Expert for all participants of the live event
Interested in joining us? Follow the link and register!
Time
(Thursday) 2:00 pm - 4:00 pm CEST
Location
Online Event
Organizer
Eurofins Genomics & Medidee
27aprAll DayMDR Soforthilfe-Sprechtag BW(All Day: tuesday) CEST
Event Details
Die neue europäische Medizinprodukteverordnung (MDR) stellt die Unternehmen der Medizintechnik bei der Umsetzung der enorm gestiegenen Anforderungen vor große Herausforderungen. Die MDR Soforthilfe BW der BIOPRO Baden-Württemberg GmbH bietet Ihnen
Event Details
Die neue europäische Medizinprodukteverordnung (MDR) stellt die Unternehmen der Medizintechnik bei der Umsetzung der enorm gestiegenen Anforderungen vor große Herausforderungen. Die MDR Soforthilfe BW der BIOPRO Baden-Württemberg GmbH bietet Ihnen an dieser Stelle Unterstützung und veranstaltet in Kooperation mit verschiedenen externen Experten MDR Sprechtage. In Einzelgesprächen können Sie Ihre individuellen Fragen zur Implementierung der Verordnung klären.
Time
All Day (Tuesday) CEST
Location
Online Event
Organizer

Event Details
[MEET THE EXPERT] Implants is organized in cooperation with the event ORTHOMANUFACTURE in 2021 and will combine two well-known
Event Details
[MEET THE EXPERT] Implants is organized in cooperation with the event ORTHOMANUFACTURE in 2021 and will combine two well-known congresses for the implant industry in Europe. This year, the concept of these events is an online congress that is designed equally for manufacturers of implants, suppliers and service providers, as well as for universities and institutes. The program includes keynote lectures, short presentations and possibilities for online discussions with the authors and presenters. During the breakout sessions, all exhibitors will be accessible in their individual room for online discussions.
Medidee will be there to answer your questions and share with you our own experience.
Main Topics for the 2021 meeting are:
- Packaging / Sterilization / Clean room
- Orthopaedics / Trauma / Spinal implants
- Instruments / Cleaning / Reprocessing
- Clinical topics
- Additive manufacturing
- Innovative production processes
- Smart devices
- MDR, Regulatories
- Safety and product quality / Validation
Join us now!
Time
28 (Wednesday) 8:00 am - 29 (Thursday) 5:00 pm CEST
Location
Online Event
Organizer
RMS Foundation
may 2021
03may9:00 am5:00 pm[ Online Seminar ] Der QM-Beauftragte (QMB)9:00 am - 5:00 pm CEST

Event Details
Der Qualitätsmanagement-Beauftragte (QMB) ist in der Stabsstellenfunktion verantwortlich für das Dokumentieren der Prozesse, die Berichterstattung an die Geschäftsleitung über die Wirksamkeit und die Förderung des Bewusstseins über regulatorische Anforderungen. Grundvoraussetzung
Event Details
Der Qualitätsmanagement-Beauftragte (QMB) ist in der Stabsstellenfunktion verantwortlich für das Dokumentieren der Prozesse, die Berichterstattung an die Geschäftsleitung über die Wirksamkeit und die Förderung des Bewusstseins über regulatorische Anforderungen. Grundvoraussetzung sind dabei Kenntnisse der Anforderungen der DIN EN ISO 13485. In Unternehmen der Medizintechnikbranche sind darüber hinaus eine Vielzahl von regulatorischen Regelungen zu beachten und einzuhalten, an die spezielle Verantwortlichkeiten und Beauftragte geknüpft sind. Die koordinierende Rolle des QMB bei der internen Struktur- und Prozessbeschreibung im QM-System, die Verantwortung und Befugnis als „Mitglied der Leitung“ und die Aufgabe im Rahmen von externen Audits und Behördeninspektionen werden anhand vieler Beispiele erläutert.
Time
(Monday) 9:00 am - 5:00 pm CEST
Location
Online Event

Event Details
This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of software as a medical device. The regulatory context will be discussed,
Event Details
This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of software as a medical device. The regulatory context will be discussed, the integration of software aspects within a medical device is reviewed and all aspects associated with IEC 62304 will be presented in order to be able to implement a compliant software development process. Join us for a 3 half days training to discover all this!
This training is given by Dr William Enns-Bray, Senior Associate from Medidee.
Time
10 (Monday) 1:00 pm - 12 (Wednesday) 4:30 pm CEST
Location
Online Event

Event Details
With the coming MDR in May 26th 2021, learn and get the most outcomes from our experts in this free online event! During this webinar, you will learn why is regulation
Event Details
With the coming MDR in May 26th 2021, learn and get the most outcomes from our experts in this free online event!
During this webinar, you will learn why is regulation so important for medical technology products, why should regulatory requirements be addressed as early as possible, what is important, and many other things.
The Medical Device Regulation (MDR) and the necessary steps until market entry are becoming more and more urgent. Regulatory know-how is necessary and offers advantages as early as the development stage and significantly secures your later success.
Join us for two half days to discover more about Regulatory Affairs and ask all your questions!
Ready to join us? Register now!
Time
18 (Tuesday) 9:15 am - 19 (Wednesday) 1:00 pm CEST
Location
Online Event
Organizer
EIT Health & Medidee
18may11:00 am12:28 pm[Webinar ] Digital Health in UK & Belgium11:00 am - 12:28 pm CEST

Event Details
[ Limited number of places ] Digital technologies have been driving a revolution in health care both for Medical Devices and IVDs. Join us on May 18th to crack business opportunities in
Event Details
[ Limited number of places ]
Digital technologies have been driving a revolution in health care both for Medical Devices and IVDs.
Join us on May 18th to crack business opportunities in digital health across the Channel!
This free webinar is organized in partnership with MedTech Wallonia and ABHI.
The Goal? Help Walloon and British businesses internationalise and improve access to both countries’ digital health ecosystems.
In this event, @Sarah El Karmoudi will be presenting the post-Brexit regulatory changes.
You will also have time to network, and learn about new trends and possibilities during the Networking Workshops!
But… The number of places are limited, do not miss this great opportunity to join us!
Ready to participate? Register now!
Time
(Tuesday) 11:00 am - 12:28 pm CEST
Location
Online Event
june 2021

Event Details
With this online training, you will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your organization to know you are prepared and
Event Details
With this online training, you will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your organization to know you are prepared and ready to host audit.
This training is given by Michael Maier, Senior Partner from Medidee.
Time
3 (Thursday) 8:30 am - 4 (Friday) 5:00 pm CEST
Location
Online Event

Event Details
Medidee partners with MedicoIndustrien to offer you a training on IEC 60601. The objective of this training is to create a general understanding of the EN 60601-series, which is the
Event Details
Medidee partners with MedicoIndustrien to offer you a training on IEC 60601. The objective of this training is to create a general understanding of the EN 60601-series, which is the product standard series for electrical medical devices and system. The course will cover the structure of the series, how to use and interpret it in a proper way. It will also cover the relation to the European market and other important markets around the world. Hands-on training sessions will be applied throughout the course. The course is based on a practical rather than theoretical viewpoint.
Time
15 (Tuesday) 8:30 am - 17 (Thursday) 12:00 pm CEST
Location
Online Event

Event Details
We invite you to join this webinar scheduled on 16th June 2021 from 6 pm to 7:30 pm. (IST), to learn more about Pennsylvania's strenghts in Life Sciences and how
Event Details
We invite you to join this webinar scheduled on 16th June 2021 from 6 pm to 7:30 pm. (IST), to learn more about Pennsylvania’s strenghts in Life Sciences and how it can benefits your business, with Philippe Etter, senior partner at Medidee.
What you can expect ?
– In-depth understanding of the possible opportunities available for Indian Companies
– Potential to grow your business and contribute to the industry.
Register now for free here
Time
(Wednesday) 6:00 pm - 7:30 pm IST
Location
Online Event
17jun7:00 am10:00 pm[Online Seminar] Accelerating diagnostics test development7:00 am - 10:00 pm BST
Event Details
Each step in a diagnostic test’s journey can influence outcomes. Advances in molecular biology, immunodiagnostics and rapid point-of-care (POC) testing are transforming diagnostics.
Event Details
Ready to participate? Register now, it’s free of charge!
Time
(Thursday) 7:00 am - 10:00 pm BST
Location
Online Event

Event Details
Medidee partners with MedicoIndustrien to offer you a training on CAPA. This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective
Event Details
Medidee partners with MedicoIndustrien to offer you a training on CAPA. This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
This training is given by Dr Amalia Tsanaka, Quality Manager and Senior Associate at Medidee.
Time
17 (Thursday) 8:30 am - 18 (Friday) 12:00 pm CEST
Location
Online Event
25jun12:30 pmWebinar : IVDR - Getting your genetic testing lab ready for May 26, 202212:30 pm CEST

Event Details
The European Commission's In Vitro Diagnostic Regulation (IVDR) comes into full effect on the 26th of May, 2022. Genetic tests will
Event Details
The European Commission’s In Vitro Diagnostic Regulation (IVDR) comes into full effect on the 26th of May, 2022. Genetic tests will now be classified as Class C, the second-highest class of devices, and health institution’s permissible use of laboratory developed tests (LDT) will change.
Speaker : Kim Rochat, Senior Partner at Medidee.
Join us for this webinar exploring how you need to adapt your wet lab and software to achieve compliance.
Register here
Time
(Friday) 12:30 pm CEST
Location
Online Event
28junAll DayMedtech Innovation Event 2021(All Day: monday) Région:Switzerland

Event Details
Medtech Innovation Event 2021 is the matchmaking event for startups, small and medium-sized enterprises (SME), service providers, investors as well as academic and global players from the medtech sector. The event
Event Details
Medtech Innovation Event 2021 is the matchmaking event for startups, small and medium-sized enterprises (SME), service providers, investors as well as academic and global players from the medtech sector.
The event consists of pitches by startups/industrial innovators and solution providers. Additionally, there will be a tabletop exhibition with a limited amount of tabletops and a 1-to-1 partnering service.
Register to this event and ask us all your questions, Medidee will have an expo booth there!
Michael Maier, Senior Partner will be here to welcome you!
Registration | until 25 June 2021
From registration to the event, there will be regular mail updates explaining what you need to do next.
Time
All Day (Monday)
Location
Switzerland Innovation Park Biel/Bienne
29jun01jul[Online Workshop] Basic of Regulatory Affairs in MedTech10:00 am - (july 1) 12:00 pm CEST

Event Details
This training provides you with the basics of regulatory affairs in MedTech with a focus on MDR and IVDR (Medical Devices and In-Vitro Diagnostic Medical
Event Details
This training provides you with the basics of regulatory affairs in MedTech with a focus on MDR and IVDR (Medical Devices and In-Vitro Diagnostic Medical Devices Regulation).
Get an overview of the regulatory landscape, hear about the basic concepts and principles and get insights into the necessary steps but also pitfalls when bringing a MedTech product to the market.
Discuss with Medidee experts about the different Steps to CE marking for Medical Devices; US Market Access for MD and V&V and Technical documentation!
Ready to participate? Register now, it’s free of charge!
Time
June 29 (Tuesday) 10:00 am - July 1 (Thursday) 12:00 pm CEST
Location
Online Event
july 2021

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
august 2021

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
26aug9:00 am11:00 amHealth Tech Regulation – Swiss AR9:00 am - 11:00 am CEST

Event Details
Seit dem 27. Mai 2021 betrachtet die EU die Schweiz in Bezug auf die Medizinprodukteregulierung (MDR) als Drittstaat. Deshalb musste die gegenseitige Anerkennung von Zulassung und Inverkehrbringung von Medizinprodukten neu
Event Details
Seit dem 27. Mai 2021 betrachtet die EU die Schweiz in Bezug auf die Medizinprodukteregulierung (MDR) als Drittstaat. Deshalb musste die gegenseitige Anerkennung von Zulassung und Inverkehrbringung von Medizinprodukten neu geregelt werden. Durch einseitige Übernahme der MDR in schweizerisches Recht ist die Voraussetzung geschaffen, um in technischer Hinsicht und bezüglich Zulassung von einer gleichwertigen Ausgangslage zu sprechen. Was sich jedoch ändert: Wer ein Medizinprodukt aus der EU in die Schweiz exportiert bzw. exportieren möchte, braucht hierzulande einen Schweizer Bevollmächtigten (Swiss authorized representative – Swiss AR). Was es dabei zu beachten gilt und was dies bezüglich Fristen, Versicherungsschutz usw. bedeutet, zeigen wir in einem Online-Gespräch mit drei ausgewiesenen Expertinnen und Experten.
Nehmen Sie an dieser Veranstaltung in Partnerschaft mit Decomplix, Effectum Medical, MTC, WKO and Medidee.
Time
(Thursday) 9:00 am - 11:00 am CEST
Location
Online Event

Event Details
This training held live at the EPFL (Switzerland) on August 31st provides you with the basics of regulatory affairs in MedTech with a focus on
Event Details
This training held live at the EPFL (Switzerland) on August 31st provides you with the basics of regulatory affairs in MedTech with a focus on MDR and IVDR (Medical Devices and In-Vitro Diagnostic Medical Devices Regulation).
Get an overview of the regulatory landscape, hear about the basic concepts and principles and get insights into the necessary steps but also pitfalls when bringing a MedTech product to the market.
Discuss with Medidee experts about the different Steps to CE marking for Medical Devices; US Market Access for MD and V&V and Technical documentation!
Ready to participate? Register now, it’s free of charge!
Time
(Tuesday) 9:00 am - 5:00 pm CEST
Location
EPFL
Station 15, Lausanne
september 2021
07sep4:00 pm[Webinar] Clinical Investigation & In Vitro Diagnostic Devices4:00 pm CEST

Event Details
With the implementation of the IVDR, clinical performance studies on In Vitro Diagnostic Medical devices are becoming a central pillar of the device’s clinical evidence. As soon as a device is
Event Details
With the implementation of the IVDR, clinical performance studies on In Vitro Diagnostic Medical devices are becoming a central pillar of the device’s clinical evidence.
As soon as a device is used for a diagnosis purpose on human samples, the EU Competent Authorities are expecting clinical evidence supporting the safety and performance of the device, when used as intended. This means that for some IVD devices, data obtained through a clinical performance study is becoming a must-have for its placement on the EU market.
But what exactly is a clinical performance study?
Which IVD devices require collection of clinical evidence through a clinical performance study?
When is the right moment in a device’s lifecycle for conducting a clinical performance study?
How do I handle clinical data gathered through previous clinical performance study?
Is it mandatory to use the ISO 20916 standard?
In order to avoid delays in the marketing approval process, it is important to understand the full clinical workflow for each type of IVD device.
Join us for this webinar during which our expert Julianne Bobela will guide you through an IVD’s Clinical workflow, including:
· The type of clinical data needed
· The device-specific needs for clinical performance studies
· The characteristics of interventional clinical performance studies
· The regulatory requirements for conducting clinical performance studies
Ready to join us? Register now!
Time
(Tuesday) 4:00 pm CEST
Location
Online Event
14sep8:15 am4:15 pmMedBraid 20218:15 am - 4:15 pm CEST Région:Switzerland

Event Details
MedBraid is a one day conference for leaders, engineers, founders, and curious observers of the medical device industry. Through educational presentation and Q&A sessions, our speakers will share new insights
Event Details
MedBraid is a one day conference for leaders, engineers, founders, and curious observers of the medical device industry.
Through educational presentation and Q&A sessions, our speakers will share new insights & ideas about the forthcoming forces shaping our industry. Speakers will also stay available to discuss your needs during our one-on-one conversation session. All the talks will be recorded and made available for our registered guests.
Speakers : Jonathan Lintott, Michael Maier, Yacine Gérard, Gilles Farron, Dr. Linda Ahnen and Laurent Grandidier.
This event is organised in partnership with Medidee, Swiss MedTech Expo and Medistri S.A.
Learn more about the schedule.
Registration are open.
Time
(Tuesday) 8:15 am - 4:15 pm CEST
Location
Luzern, Switzerland
Messe Luzern Horwerstrasse 87

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Thank you to our partners EIT Health Germany, Baden Campus, BioCon Valley, Biosaxony, Medical Valley & Forum MedTech Pharma
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
14sep4:00 pm[Webinar] Performance Evaluation Plan & Report4:00 pm CEST

Event Details
With the implementation of the IVDR, for In Vitro Medical devices (IVD), a performance evaluation needs to be conducted to demonstrate a device’s performance and safety evidence. This performance evaluation
Event Details
With the implementation of the IVDR, for In Vitro Medical devices (IVD), a performance evaluation needs to be conducted to demonstrate a device’s performance and safety evidence. This performance evaluation follows a defined Performance Evaluation Plan (PEP) and is documented within a Performance Evaluation Report (PER).
As soon as a device is used for a diagnosis purpose on human samples, the EU Competent Authorities are expecting analytical and clinical evidence, supporting the safety and performance of the device, when used as intended. This performance and safety evidence is based on the assessment and analysis of data related to the device’s scientific validity, as well as its analytical and clinical performance.
But what exactly is a performance evaluation and what does it consist of?
What are the IVD devices which need a performance evaluation?
How do I establish the strategy for performance and safety substantiation?
When is the right moment to start with a device’s performance evaluation?
What about legacy devices?
Is there any guidance or a standard that I can use?
In order to avoid delays in the development and marketing approval process, it is important to understand the full workflow of an IVD’s performance evaluation.
Join us for this webinar during which our expert Julianne Bobela will guide you through an IVD’s performance evaluation workflow, including:
· The documentation which constitutes a performance evaluation
· The type of data needed to support a device’s performance and safety
· The device-specific needs for performance evaluation, based on its group, risk class, and intended purpose
· The lifecycle of a performance evaluation and its interconnection with other documents of the technical documentation
Ready to join us? Register now!
Time
(Tuesday) 4:00 pm CEST
Location
Online Event

Event Details
Êtes-vous une entreprise MedTech basée en France ? Avez-vous des questions à propos de la MDR, IVDR ou d’autres questions relatives au développement vos dispositifs médicaux ? Profitez d’une heure
Event Details
Êtes-vous une entreprise MedTech basée en France ? Avez-vous des questions à propos de la MDR, IVDR ou d’autres questions relatives au développement vos dispositifs médicaux ?
Profitez d’une heure gratuite de consultation avec nos experts! Vous pourrez leur adresser toutes vos questions, concernant, par exemple, la classification de vos dispositifs, mais aussi les stratégies de vérification et validation, ou encore l’impact des nouvelles réglementations sur la santé digitale !
Nos experts Sarah El Karmoudi ainsi que Pierre Geens seront à votre écoute !
Plus d’informations ici.
Faites vite, seulement 9 rendez-vous sont prévus !
Time
(Friday) 8:30 am - 5:00 pm CEST
Location
Online Event
23sep9:00 am5:00 pm[Free Regulatory Consultation] Italian area9:00 am - 5:00 pm CET Région:Italy

Event Details
Join us for an exclusive free check of your situation with regard to the new regulatory requirements. If you are an Italian-based company with questions induced by the new MDR (classification, clinical
Event Details
Join us for an exclusive free check of your situation with regard to the new regulatory requirements.
If you are an Italian-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices, and in vitro diagnostics), this event is for you!
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Time
(Thursday) 9:00 am - 5:00 pm CET
Location
Online Event
october 2021

Event Details
[FREE WEBINAR for Australian-based companies] With the deployment of MDR and IVDR, there is significant pressure to update the compliance documentation of medical devices, within a short amount of time. The
Event Details
[FREE WEBINAR for Australian-based companies]
With the deployment of MDR and IVDR, there is significant pressure to update the compliance documentation of medical devices, within a short amount of time.
The notified bodies are also facing increasing workload due to a large number of conformity assessments.
Meanwhile, some companies identify that some products may be easier to bring on the US market during this burdensome EU phase.
This webinar covers both sides of this situation:
What can be done to get existing devices approved under the new EU regulations
How does the FDA pre-submission meetings help in the approval process?
What is the best starting point for innovative companies: EU or US approval?
Our experts Philippe Etter and Dr Milind Raje will guide you through the changing trends in EU and FDA approvals for medical devices and IVDs:
· MDR current status (including IVDR touch)
· The latest guidance from Notified Bodies
· Dealing with Notified Bodies
· Tactics for existing portfolio of products
· Why are innovative companies trending towards US?
· Status of availability of FDA
· General Regulatory trends
Ready to join us? Register now!
Time
(Thursday) 7:30 am CEST
Location
Online Event

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Thank you to our partners EIT Health Germany, Baden Campus, BioCon Valley, Biosaxony, Medical Valley & Forum MedTech Pharma
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
26oct9:30 am5:00 pmMedTech Wallonia Day9:30 am - 5:00 pm CEST Région:Belgium

Event Details
Vous êtes un professionnel de la santé, une société innovante, une unité académique, un centre de recherche intéressé ou actif dans les MedTech et vous voulez tout savoir sur le
Event Details
Vous êtes un professionnel de la santé, une société innovante, une unité académique, un centre de recherche intéressé ou actif dans les MedTech et vous voulez tout savoir sur le développement de l’écosystème des dispositifs médicaux sur le territoire de la Wallonie ?
Alors cette journée est faite pour vous !
3 acteurs wallons se sont réunis autour de la marque MedTech Wallonia afin de faire grandir cet écosystème ensemble :
BioWin – The Health Cluster of Wallonia , WSL, incubateur wallon des sciences de l’ingénieur et Pôle MecaTech.
Rejoignez Medidee pour une journée dédiée aux secteurs de la santé digitale, des dispositifs médicaux et des diagnostics In Vitro.
Time
(Tuesday) 9:30 am - 5:00 pm CEST
Location
Actibel
Avenue d'Ecolys 2, BTE 2
november 2021

Event Details
The MEGRA (M edium E uropean G ompany for R egulatory A ffairs) is an association of professionals from mainly German-speaking countries, who work professionally in the officially regulated area
Event Details
The MEGRA (M edium E uropean G ompany for R egulatory A ffairs) is an association of professionals from mainly German-speaking countries, who work professionally in the officially regulated area of pharmaceuticals, medical devices, diagnostics and related fields.
In particular, they deal with the tasks and work necessary for the approval or registration of human and veterinary medicinal products as well as medicinal and auxiliary materials as well as the related pharmaceutical legal aspects and questions about clinical trials, product information, drug safety, etc.
During this event, Michael Maier (Medidee) and Daniel Delfosse (SwissMedTech) will discuss Medical Devices and Demarcation Questions.
Ready to join us? More information and registration here.
Time
(Thursday) 9:15 am - 4:45 pm
Location
Campus Northwestern Switzerland University of Applied Sciences (FHNW)
Organizer
MEGRAoffice@megra.org Megra eV, Leopoldstrasse 11a, 80802 Munich, Germany

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Thank you to our partners EIT Health Germany, Baden Campus, BioCon Valley, Biosaxony, Medical Valley & Forum MedTech Pharma
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
15novAll Day18Medica(All Day) CET Région:Deutschland

Event Details
Join us from November 15th to 18th 2021 at the World Forum for Medicine, MEDICA in Düsseldorf, Germany! Meet Medidee’s team at booth n°
Event Details
Join us from November 15th to 18th 2021 at the World Forum for Medicine, MEDICA in Düsseldorf, Germany!
Meet Medidee’s team at booth n°15G22 (Hall 15)
During 3 days, we will be here to respond to all your regulatory, clinical, and quality assurance questions!
Medica is the World’s largest healthcare & life sciences event running for more than 40 years.
We can’t wait to meet you!
Medidee – Compliance with Relevance
Time
november 15 (Monday) - 18 (Thursday) CET
Location
Düsseldorf, Germany
Fair ground Düsseldorf
december 2021

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free 👉 here
⚠️ Hurry, slots go fast! First come, first served ⚠️
Medidee – Compliance with Relevance
Thank you to our partners EIT Health Germany, Baden Campus, BioCon Valley, Biosaxony, Medical Valley & Forum MedTech Pharma
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
january 2022
No Events
february 2022

Event Details
[Online Workshop] Digital Health | The Regulatory Landscape Get an overview of the regulatory landscape, hear about the basic concepts and principles, get insights into the necessary steps and anticipate typical
Event Details
[Online Workshop] Digital Health | The Regulatory Landscape
Get an overview of the regulatory landscape, hear about the basic concepts and principles, get insights into the necessary steps and anticipate typical pitfalls when bringing a digital health product to the market.
Training Objective
· Get an overview of the regulatory landscape and requirements surrounding digital health applications
· Understand the major principles, concepts and processes
· Learn to sequence the necessary steps and build awareness of possible pitfalls when bringing a digital health product to the market
· Know where and how to find required information
Our experts Kim Rochat, Dr Gustavo Hernandes and Dr Stamatia Pagoulatou, will provide you with the basics of regulatory affairs related to digital health.
Interested in joining us? Register here
Time
1 (Tuesday) 10:00 am - 3 (Thursday) 12:00 pm CET
Location
Online Event
Organizer
Business & Economic Development (AWA), Canton of Zurich | ETH Zurich Industry Relations | Life Science Zurich Business Network

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CET
Location
Online Event
16feb12:00 pm1:30 pm[Webinar] MDR & IVDR compliance for US companies12:00 pm - 1:30 pm EST Région:US
![[Webinar] MDR / IVDR compliance :Roadmap to the new EU expectations](https://medidee.com/wp-content/uploads/2022/01/Posts-LinkedIn_Webinars-2021-1.png)
Event Details
[Webinar] MDR & IVDR compliance for US companies With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified
Event Details
[Webinar] MDR & IVDR compliance for US companies
With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified Bodies.
US medical device and IVD companies with established products have limited choice besides upgrading documentation because EU remains a dense market with 750 million inhabitants and a large hospital every other 20 miles.
For innovative companies, the question remains complex because the timelines for starting a clinical trial on complex devices remain shorter in the EU, whereas simple devices, such as Digital Health solutions, are clearly easier to develop in the USA.
This webinar covers both aspects of this situation:
· What can be done to get existing devices approved under the new EU regulations
· What are tactics for innovative companies
Our experts from our office of Philadelphia, Tamara Lewis, Paige Sutton-Smith, and Philippe Etter, will guide you through the changing trends in EU for medical devices and IVDs:
· MDR current deployment status (including IVDR touch)
· Latest guidances from Notified Bodies
· Planning of conformity assessments for MDR / IVDR transition
· Dealing with Notified Bodies, where to go
· EC-REP, UK-REP, CH-REP
· Clinical tactics in the EU
Interested in joining us? Register here!
Time
(Wednesday) 12:00 pm - 1:30 pm EST
Location
Online Event
17feb5:00 pm6:00 pm[Free Online Info Event] MDR / IVDR | CARAQA Program5:00 pm - 6:00 pm CET

Event Details
Learn about the latest regulatory changes in MedTech and get introduced to the certified high-level training course CARAQA (= clinical, regulatory, and quality affairs for medical devices and in-vitro diagnostic
Event Details
Learn about the latest regulatory changes in MedTech and get introduced to the certified high-level training course CARAQA (= clinical, regulatory, and quality affairs for medical devices and in-vitro diagnostic medical devices).
This online info event is devided into two parts:
In the first half, University Professor Folker Spitzenberger of TH Lübeck and industry expert Philippe Etter of Medidee share their theoretical and practical insights about the new European regulatory framework for medical devices (Regulation (EU) 2017/745 on medical devices – „MDR“ – and Regulation (EU) 2017/746 on in vitro diagnostic medical devices – „IVDR“) which leads to numerous consequences for all stakeholders of the medical device sector.
In the second half, you will be introduced to the certified high-level training in clinical, regulatory, and quality affairs for medical devices and in-vitro diagnostic medical devices: CARAQA.
Interest in joining the event? Registration here.
Cannot attend? No problem! Just register and we will send you a video recording of the online Info event.
Time
(Thursday) 5:00 pm - 6:00 pm CET
Location
Online Event
march 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CET
Location
Online Event
17mar4:30 pm6:00 pm[WEBINAR] MDR & IVDR compliance for Australian companies4:30 pm - 6:00 pm GMT+10
![[WEBINAR] MDR & IVDR compliance for Australian companies - March 17th 2022](https://medidee.com/wp-content/uploads/2022/02/Posts-LinkedIn_Webinars-2021-2.png)
Event Details
[Webinar] MDR & IVDR compliance for Australian companies With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified
Event Details
[Webinar] MDR & IVDR compliance for Australian companies
With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified Bodies.
Australian medical device and IVD companies with established products have limited choice besides upgrading documentation because EU remains a dense market with 750 million inhabitants and a large hospital every other 20 miles.
For innovative companies, the question remains complex because the timelines for starting a clinical trial on complex devices remain shorter in the EU, whereas simple devices, such as Digital Health solutions, are clearly easier to bring to market in US.
This webinar covers both aspects of this situation:
· What can be done to get existing devices approved under the new EU regulations
· What are tactics for innovative companies
Our experts Philippe Etter and Dr Milind Raje will guide you through the changing trends in EU for medical devices and IVDs:
· MDR current deployment status (including IVDR touch)
· Latest guidances from Notified Bodies
· Planning of conformity assessments for MDR / IVDR transition
· Dealing with Notified Bodies, where to go
· EC-REP, UK-REP, CH-REP
· Clinical tactics in the EU
Interested in joining us? Register here!
Time
(Thursday) 4:30 pm - 6:00 pm GMT+10
Location
Online Event

Event Details
Êtes-vous une entreprise MedTech basée en France ? Avez-vous des questions à propos de la MDR, IVDR ou d’autres questions relatives au développement vos dispositifs médicaux ? Profitez d’une heure gratuite
Event Details
Êtes-vous une entreprise MedTech basée en France ? Avez-vous des questions à propos de la MDR, IVDR ou d’autres questions relatives au développement vos dispositifs médicaux ?
Profitez d’une heure gratuite de consultation avec nos experts! Vous pourrez leur adresser toutes vos questions, concernant, par exemple, la classification de vos dispositifs, mais aussi les exigences d’évaluation clinique de dispositifs innovants, ou encore l’évaluation de votre positionnement réglementaire!
Nos experts Sarah El Karmoudi ainsi que Pierre Geens seront à votre écoute !
Plus d’informations ici.
Faites vite, seulement 8 rendez-vous sont prévus !
Time
(Tuesday) 8:30 am - 4:30 pm CET
Location
Online Event
april 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
may 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
31may9:00 am12:30 pmMDR Experience Day9:00 am - 12:30 pm CEST Région:Switzerland

Event Details
Importing, marketing and reprocessing Medical Devices according to the Swiss law poses great challenges to MedTech industry professionals. That’s why we are joining the MDR Experience Day, organised by Swiss-Medtech,
Event Details
Importing, marketing and reprocessing Medical Devices according to the Swiss law poses great challenges to MedTech industry professionals.
That’s why we are joining the MDR Experience Day, organised by Swiss-Medtech, and sharing our experience and expertise about “Obligations of economic actors in Switzerland”, and “Requirements for the maintenance and reprocessing of Medical Devices”.
Join Michael Maier from Medidee on May 31st in Bern, for this in-person event happening simultaneously in German and French.
Time
(Tuesday) 9:00 am - 12:30 pm CEST
Location
Sitem, Freiburgstrasse 3, 3010 Bern, Felix Frey Auditorium
june 2022

Event Details
Look forward to the GS1 Excellence Days: 2 days of gathering know-how and gaining insights into the current best practice cases. This also means exchanging ideas with experts and networking
Event Details
Look forward to the GS1 Excellence Days: 2 days of gathering know-how and gaining insights into the current best practice cases. This also means exchanging ideas with experts and networking with industry giants.
Join us on June, 9th on this In-person event which brings together top-class keynote speakers from strategically relevant business areas such as consumer goods, transport & logistics, technical industries and healthcare.
Michael Maier will provide you with all his knowledge regarding the process and constraints of importing Medical Devices into Switzerland.
Check the full program and register here
Time
8 (Wednesday) 10:00 am - 9 (Thursday) 4:00 pm CEST
Location
Kursaal Bern
Kornhausstrasse 3, 3013 Bern, Switzerland

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event

Event Details
Basics of Regulatory Affairs for Start-ups in Medical Technology – a two days workshop This two-day free-of-charge workshop is the first of a seminar series addressing topics ranging from basic regulatory
Event Details
Basics of Regulatory Affairs for Start-ups in Medical Technology – a two days workshop
This two-day free-of-charge workshop is the first of a seminar series addressing topics ranging from basic regulatory affairs to reimbursement strategies.
This is your chance to acquire basic and some advanced regulatory know-how, that will help you to better understand the regulatory requirements of the health care market.
A joint event from Innovation in Health, Medidee Services, EIT Health RIH Germany-Switzerland and BadenCampus.
Click here for more information and registration details to join this free event.
Time
14 (Tuesday) 9:30 am - 15 (Wednesday) 2:00 pm CEST
Location
Online Event
16jun5:00 pmCARAQA program at HEIG-VD, Switzerland - Info Session5:00 pm CEST Région:Switzerland

Event Details
Free onsite info session to discover CARAQA program in Yverdon-les-Bains on June 16th Evolve towards your company’s decision-making centers and play a key role in maintaining your company’s competitiveness and sustainability,
Event Details
Free onsite info session to discover CARAQA program in Yverdon-les-Bains on June 16th
Evolve towards your company’s decision-making centers and play a key role in maintaining your company’s competitiveness and sustainability, faced with regulatory challenges.
Join this 6 months program to become a Clinical Affairs, Regulatory Affairs & Quality Assurance specialist for Medical Devices and IVDs.
During 1 hour, Didier Maillefer from HEIG-VD and Philippe Etter from Medidee will tell you more about this CARAQA program in Yverdon-les-Bains, Switzerland, offered in partnership with HEIG-vd, Haute Ecole d’ingénierie et de gestion, from the canton of Vaud.
Next starting date is in September 2022, want to know more?
Reserve your seat now and join us on June 16th at 5:00 PM CEST in the EPFL Innovation Park, Building F, Room Luna
Time
(Thursday) 5:00 pm CEST
Location
EPFL Innovation Park, Building F, Room Luna
Organizer
HEIG-VD

Event Details
MEDTECH SUMMIT 2022: THE FLAGSHIP REGULATORY EVENT OF THE YEAR Join one of the major MedTech RA events in Europe! Bringing EU Commission, Competent Authority, Notified Body and industry experts
Event Details
MEDTECH SUMMIT 2022: THE FLAGSHIP REGULATORY EVENT OF THE YEAR
Join one of the major MedTech RA events in Europe!
Bringing EU Commission, Competent Authority, Notified Body and industry experts together to discuss the evolving global regulatory landscape.
Dr Silvia Anghel and Dr Valentina Lintas, both from Medidee, will be present in this hybrid event as exhibitors and speakers.
IN-VITRO DIAGNOSTICS REGULATION AND STRATEGY
On June 24th, Dr Silvia Anghel, Senior Consultant at Medidee, will provide you with a presentation to Identify and Justify Intended Purpose:
– What is the intended purpose and where is this information found in the technical documentation and in the information provided by the manufacturer?
– How detailed should it be?
– What is the strategic link between intend purpose and clinical evidence?
For more information about the program and the registration, click here
Time
20 (Monday) 9:00 am - 24 (Friday) 5:00 pm BST (British Summer Time, GMT+1)
Location
Clayton Hotel Burlington Road, Dublin

Event Details
[WEBINAR] Clinical Evaluation Reports - Updates related to MDR for Australian companies During this webinar, we will share with you the latest updates related to the preparation of clinical evaluation reports
Event Details
[WEBINAR] Clinical Evaluation Reports – Updates related to MDR for Australian companies
During this webinar, we will share with you the latest updates related to the preparation of clinical evaluation reports (CER). Currently, we observe that the reviewers of Notified Bodies during MDR conformity assessments are gradually converging in terms of review practices and acceptance criterion.
Our expert Dr. Jérôme Randall will guide you through the updates related to MDR for Australian companies:
Understand the notions of “performance based CER” and “well established technologies”, as well as the methods for scoping and launching simplified PMCF (Post Market Clinical Follow Up) studies for gathering the clinical data that may be missing.
Interested in joining us? Check the registration details here!
Time
(Thursday) 4:30 pm - 6:00 pm GMT+10
july 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
august 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event

Event Details
Your last chance to ask all your questions! Free online info session to discover CARAQA program in Yverdon-les-Bain, on August 22th Evolve towards your company’s decision-making centers and play a
Event Details
Your last chance to ask all your questions! Free online info session to discover CARAQA program in Yverdon-les-Bain, on August 22th
Evolve towards your company’s decision-making centers and play a key role in maintaining your company’s competitiveness and sustainability, faced with regulatory challenges.
Join this 6 months program to become a Clinical Affairs, Regulatory Affairs & Quality Assurance specialist for Medical Devices and IVDs.
During 1 hour, Didier Maillefer from HEIG-VD and Elena Lucano from Medidee will tell you more about this CARAQA program in Yverdon-les-Bains, Switzerland, offered in partnership with HEIG-vd, Haute Ecole d’ingénierie et de gestion, from the canton of Vaud.
Next starting date is in September 2022, want to know more?
Join us on August 22th at 5:30 PM CEST. Teams link is coming soon!
Time
(Monday) 5:30 pm CEST
Location
Online Event
Organizer
HEIG-VD
september 2022
05sep4:00 pm[WEBINAR] Build compliant Technical Documentation (TD) under MDR4:00 pm CEST

Event Details
[WEBINAR] Build compliant Technical Documentation (TD) under MDR Did you know it takes between 6 and 18 months from application to issuance of the MDR certificate for 80% of the companies? Did
Event Details
[WEBINAR] Build compliant Technical Documentation (TD) under MDR
Did you know it takes between 6 and 18 months from application to issuance of the MDR certificate for 80% of the companies?
Did you know 50% of the submitted TD are incomplete at first?
To expedite the Technical Documentation review process by the Notified Body and avoid extra costs and delays (which potentially could make your company miss the May 2024 deadline), your technical documentation submission needs to be right the first time!
Medidee supports your MDR transition process. During this webinar, our experts Lydie Moreau and Philippe Etter will tell you all about:
– What are the additional requirements of MDR compared to previous directives
– What is the structure your TD should comply to
– How to make sure you have a clear traceability thread within your TD to demonstrate compliance to all GSPRs
Interested in joining us? Register here!
Time
(Monday) 4:00 pm CEST
Location
Online Event

Event Details
Free info session to discover CARAQA program in Muttenz on September 6th Progress towards your company’s decision-making centers and play a key role in maintaining your company’s competitiveness and
Event Details
Free info session to discover CARAQA program in Muttenz on September 6th
Progress towards your company’s decision-making centers and play a key role in maintaining your company’s competitiveness and sustainability while successfully navigating all the regulatory challenges.
Join this 6 months program to become a Clinical Affairs, Regulatory Affairs & Quality Assurance specialist for Medical Devices and IVDs.
During 1:30, David Hradetzky from FHNW and Philippe Etter from Medidee will tell you more about this CARAQA program in Muttenz, Switzerland, offered in partnership with FHNW, The University of Applied Sciences and Arts from the Northwestern Switzerland.
Next starting date is in January 2023, want to know more?
Reserve your seat now and join us on FHNW Campus on September 6th from 6 to 7:30PM CEST.
Book your seat here.
Time
(Tuesday) 6:00 pm - 7:30 am CEST
Location
Campus Northwestern Switzerland University of Applied Sciences (FHNW)

Event Details
Join us live on FHNW Muttenz Campus for the next CARAQA FHNW Info session on September 6th! Prepare yourself for the next CARAQA program which will start in January 2023! Philippe
Event Details
Join us live on FHNW Muttenz Campus for the next CARAQA FHNW Info session on September 6th!
Prepare yourself for the next CARAQA program which will start in January 2023!
Philippe Etter and David Hradetzky will present you the program and answer all your questions.
Be part of the next CARAQA Muttenz class and become a Clinical Affairs, Regulatory Affairs, and Quality Assurance specialist with this recognized training!
Our Certificates of Advanced Studies is sponsored by Swiss Medtech and Medidee.
Click here to book your seat for the Info session
For additional info on all our programs, visit Caraqa’s website
Contact us for any request at training@medidee.com
Time
(Tuesday) 6:00 pm - 7:30 pm CEST
Location
Campus Northwestern Switzerland University of Applied Sciences (FHNW)

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event

Event Details
CARAQA UCLouvain online info event Join us on September 29th at 5:00 PM to learn more about the CARAQA program in Belgium! Progress towards your company’s decision-making centres and play a key
Event Details
CARAQA UCLouvain online info event
Join us on September 29th at 5:00 PM to learn more about the CARAQA program in Belgium!
Progress towards your company’s decision-making centres and play a key role in maintaining your company’s competitiveness and sustainability while successfully navigating all the regulatory challenges.
Be part of the 4th edition CARAQA UCLouvain in Belgium, and become a Clinical Affairs, Regulatory Affairs, and Quality Assurance specialist with this recognised training.
Next starting date is 13th January 2023, want to know more? Elena Lucano, Pierre Geens and Renaud Ronsse will answer all your questions about the program.
Click here to access to event page, and confirm your attendance.
Contact us for any request at hello@caraqa.com
Time
(Thursday) 5:00 pm - 6:00 pm CEST
Location
Online Event
october 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CEST
Location
Online Event
november 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CET
Location
Online Event
11novAll Day[SEMINAR] "Basics of Regulatory Affairs in MedTech"(All Day: friday) CET Région:Spain

Event Details
Face the current Regulatory Framework with Confidence Join our next seminar on November 11th, in Toledo, Spain, and get ready to face the current Regulatory Framework with confidence! The Seminar "Basics of
Event Details
Face the current Regulatory Framework with Confidence
Join our next seminar on November 11th, in Toledo, Spain, and get ready to face the current Regulatory Framework with confidence!
The Seminar “Basics of Regulatory Affairs in MedTech” organized and led by Medidee’s expert consultants, aims to provide professionals in the field of Medical Devices with an introduction to the Regulations, Challenges and Good Practices that are necessary to comply with the current European Framework.
For who? Researchers and employees from start-ups, SMEs or any other company in the field of Medical Devices are welcome to join us at this event, conducted simultaneously in Spanish and English.
Entrance is free but places are limited, so make sure to register as soon as possible here.
Time
All Day (Friday) CET
Location
Hospital Nacional de Parapléjicos - Toledo, Spain
december 2022

Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you! Together
Event Details
If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!
Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.
During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!
Find out more and sign up for free: here
Hurry, slots go fast! First come, first served.
Medidee – Compliance with Relevance
Time
(Tuesday) 9:00 am - 4:00 pm CET
Location
Online Event
january 2023
No Events
february 2023
No Events