Join us freely on August 31st 2021and get an overview ofthe regulatory landscapeand regulatory stakeholdersin MedTech!

When?

Tuesday, 31st August 2021 from 9AM – 5PM

Where?

In Switzerland, at the EPFL, Auditorium SG1

Fees?

This workshop is FREE OR CHARGE!
You just have to pre-register, and one of our Medidee Team Member will be back to you to confirm your participation. Be careful, the number of places is limited!

Registrations are closed!
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Aim of this free training

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 the experts.

Training objectives

  • Get an overview of the regulatory landscape and regulatory stakeholders in MedTech
  • Understand the major principles, concepts, and processes
  • Learn to sequence the necessary steps and build awareness of possible pitfalls when bringing a MedTech product to the market
  • Know where and how to find the required information

Target Audience

  • Researchers in the field of translational medicine
  • Employees from spin-offs, start-ups and SMEs, who intend to bring a product to the market
  • Employees from companies interested in getting an overview on regulatory affairs
  • Investors in medical devices who would like to understand risks and opportunities regarding the evolving regulatory framework in EU

Prerequisites

  • Affinity to or involvement in MedTech or Life Sciences
  • Basic understanding of good practices in product development and innovation
  • Technical/scientific background or commercial background linked to Life Sciences products

Program of the day

MORNING

09:00 Welcome
Frédéric Reymond, Key Account Manager, Innovaud
André Catana, EPFL Start-up Unit
Niels Lion, Deputy Director Center for Neuroprosthetics, EPFL
09.15–10.45 Introduction – Steps to CE Mark for Medical Devices
Dr. Jurjen Zoethout, Chief Operating Officer, Medidee Services

    • MDR / IVDR
    • Medical device classification – conformity assessment
    • General Safety and Performance Requirements (GSPR)
    • State of the art concept – principle of presumption of conformity
    • Role of Notified Bodies and working with Notified Bodies
    • Status update – implementation of MDR / IVDR
    • Adoption of EU legal framework in Switzerland

 

Pause café
11.00 – 12.00 V&V and Technical Documentation
Dr. Valentina Lintas, Senior Associate, Medidee Service

  • Setting up a design & development process
  • From user requirements to design validation
  • Design verification and pre-clinical validation
  • Technical documentation as evidence for compliance

AFTERNOON

13.00–13.45 Clinical Evidence

Dr. Valentina Lintas, Project Associate, Medidee Services

  • Clinical data, clinical evaluation, and equivalence discussion
  • Post market surveillance & post market clinical follow-up
13.45 – 14.45 US Market Access for Medical Devices

Dr. Elena Lucano, Project Associate, Medidee Services

  • Regulatory framework
  • Classification: 510(k), De Novo, HDE, PMA
  • FDA medical devices databases
  • Pre-submission, Breakthrough, and STeP programs
  • Differences between US and EU regulatory frameworks

 

Pause café

15.00–15.45 Digital Health
Dr. Elena Lucano, Project Associate, Medidee Services

  • Medical device software qualification & classification in EU/US
  • Cybersecurity, artificial intelligence, applicable standards & guidance
16.00 – 16.30 Start-up and Regulatory – Avoiding Pitfalls
Dr. Jurjen Zoethout, Chief Operating Officer, Medidee Services

  • Milestones of a medical device innovation project, a different view

 

16.30–16.45 Closing words
Frédéric Reymond, Key Account Manager, Innovaud
Niels Lion, Deputy Director Center for Neuroprosthetics, EPFL

Ready to join us?

Reserve your seat!