Medtech Symposium: «CE-Marking of Medical Devices: Navigating the new Regulatory Framework»
BioAlps and Integrated Scientific Services AG (ISS) in collaboration with the Swiss Biotech Association and the Swiss Chemical Society organise a Medtech symposium on Thursday 8 October to provide information to Medtech companies regarding the CE-marking process, specifically within the new EU MDR which has been postponed to May 2021 due to Covid-19.
Swiss Industry experts will share their experience and recommendation to cope with the new requirements and timelines.
Among other topics, the challenges regarding the establishment of a product registration strategy in such a context, the interaction with the main stakeholders, the Mutual Recognition Agreement (MRA) between EU and CH, the lack of qualified resources and the generation of clinical data will be addressed at the round-table
Chair: Dr Marie Gaumet, Business Development & Project Management, Western Switzerland, ISS AG (Geneva, GE)
- 10:00 – 10:30 | Introduction
Hansjörg Riedwyl, CEO & co-founder, Senior Consultant, ISS AG (Biel, BE)
- 10:30 – 11:45 | Round-Table
Fernand Terradas, Regulatory Affairs Program Manager, Medtronic Europe (Tolochenaz, VD)
Laurent-Dominique Piveteau, CEO, Debiotech (Lausanne, VD)
Timothée Deblock, Head of Quality, EMS Electro Medical Systems (Nyon, VD)
Michela Peisino, Co-Director Regulatory Affairs and Quality Management, Ziemer Ophthalmic Systems (Port, BE)
Marta Stepien, Clinical & Regulatory Affairs, Sleepiz (Zurich, ZU)
- 11:45 – 12:00 | Wrap-up
Moderator: Dr Marie Gaumet, Business Development & Project Management, Western Switzerland, ISS AG (Geneva, GE)
- 12:00 - 12:30 | SBA Success Story Award winners lead by example
Dr Michael Altorfer, CEO Swiss Biotech Association
Presentation InnO stage
|
11:00 |
Dipl. Phys. Eng. Cosmin Vatra, Aseptconn AG |
|
14:00 |
Dr. Mio Mülthaler, Berkeley Lights |
|
15:00 |
Dipl. Phys. Eng. Cosmin Vatra, Aseptconn AG |
