Events Archive

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

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!

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.

[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!

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.

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.

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!

[ 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!

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.

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.

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

Ready to participate? Register now, it’s free of charge!

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.

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

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.

Ready to participate? Register now, it’s free of charge!

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

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

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.

Anmelden

Ready to participate? Register now, it’s free of charge!

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!

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.

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

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!

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 !

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

[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!

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

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.

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.

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

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

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

[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

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

[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!

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.

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

[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!

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 !

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

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

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.

Details and registration here

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

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

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.

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

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

[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!

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

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

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!

[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!

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.

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

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

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

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

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

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.

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