Workshop Basics of Regulatory Affairs in Medtech

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Datum 21.10.2019
Zeit 10:00 - 16:45
Ort ETH Zürich-Hönggerberg, Building HIT E 51 (Siemens Auditorium), Wolfgang-Pauli-Strasse 27, 8093 Zürich

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Titelbild Workshop Basics of Regulatory Affairs in Medtech

This training provides you with the basics of regulatory affairs in Medtech with the 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.

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10.00 - Welcome
Danielle Spichiger, President Life Science Zurich Business Network, Director Cluster Life Sciences, Business and Economic Development (AWA), Canton of Zurich
Dr. Urs Zuber, Head Industry Relations, ETH Zurich

10.10-12.15 - Introduction – Steps to CE Mark for Medical Devices
Michael Maier, Senior Partner, Medidee Services
• 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

12.15-13.15 - Lunch and Networking

13.15-14.10 - V&V and Technical Documentation
Dr. Linda Ahnen, Scientific Expert, Medidee Services
• Setting up a design & development process
• From user requirements to design validation
• Design verification and pre-clinical validation
• Technical documentation as evidence for compliance

14.10-15.00 - Clinical Evidence
Dr. William Enns-Bray, Scientific Expert, Medidee Services
• Clinical data, clinical evaluation and equivalence discussion
• Post market surveillance & post market clinical follow-up

15.00-15.20 - Coffee Break

15.20-16.20 - US Market Access for Medical Devices
Dr. Jurjen Zoethout, Site Manager, Medidee Services
• Regulatory framework
• Classification: 510(k), De Novo, HDE, PMA
• FDA medical devices databases
• Pre-submission programme
• Differences between US and EU regulatory frameworks

16.20-16.45 - Start-up and Regulatory – Avoiding Pitfalls
Michael Maier, Senior Partner, Medidee Services
• Milestones of a medical device innovation project, a different view

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Target Audience
• Researchers in the field of translational medicine
• Employees from spin-offs, startups 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
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Workshop Size

Max. 50 participants
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CHF 100 incl. coffee break and lunch

The workshop is a joint initiative of the Division Business and Economic Development (AWA) of the Canton of Zurich, ETH Zurich Industry Relations and Life Science Zurich Business Network.


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