Events Archive

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

The seminar “Medical Devices – Managing Current Regulatory Hurdles” aims to provide MedTech industry professionals with exclusive insights into the European and Australian Medical Device and IVD Regulatory Environment.

With presentations from two leading global actors in the field, you will enjoy a rare opportunity to meet and hear from experts in the process of bringing a wide range of Medical Devices to market.

The event is followed by a networking session, where you will get the chance to interact closely with presenters and fellow industry professionals, further enriching your takeaways from this seminar.

More info about the program and registrations here.

Limited to 50 spots – Secure Yours Now!

We look forward to seeing you on March 9th in Sydney!

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 seront à votre écoute !

Plus d’informations ici.

Réservez votre session gratuite sans attendre, seulement 8 créneaux sont prévus !

Medidee/Veranex will be part of the 6th Swiss Symposium in Point-of-Care Diagnostics, the successful event that brings medical, IVD industry, and research representatives together.

Our experts Dr Silvia Anghel, Dr Julianne Bobela, and Kim Rochat will be present among other speakers for a dedicated afternoon on Regulation and Investment related to Point of Care Diagnostics, on Wednesday, 25th of October 2023.

Get insights on the challenging aspects of regulations (In Vitro Diagnostic Regulation) and investment.

Learn more about the 1st Day program here

Book your ticket here

We look forward to meeting you there!