Get to know the centerpieces of the new EU Medical Devices Regulation
- Get to know the centerpieces of the new EU Medical Devices Regulation
- Learn about the fringes of medical devices and borderline products
- Discover the opportunities and risks of defining your product as a medical device
- Discover the importance of a Quality Management System
- General market and post market considerations (e.g., materiovigilance)
- Hear about political differences between Switzerland and the EU regarding the continuation of a common market for medical devices
- What to keep an eye on: future regulations, Eudamed, etc.
Who should attend
This workshop will be relevant to life sciences companies, in particular those in the medtech sector: top management, team leaders, regulatory managers, medical/clinical heads, product and project managers, etc. to prepare for the new EU (and Swiss) Medical Devices Regulation and navigate these yet unknown straits.
The workshop will be held in English.
Date: October 27th 14:00 – 15:30
Andreas Balsiger Betts is a senior advisor at Sidley Austin. He advises on complex regulatory matters across the life sciences spectrum, drawing on his broad experience and in-depth knowledge of Swiss regulations.
Josefine Sommer is a senior associate at Sidley Austin. She advises clients on European Law relevant to medical devices, in vitro diagnostics, pharmaceutical products as well as novel foods and chemicals.
Nayem Akhtar is the Managing Consultant at DevicePharm Consultancy, who are based in London and specialise in providing Quality and Regulatory Compliance support to Medical Device companies within Europe.
To attend, registration is mandatory so please sign up HERE and get the link to the virtual meeting a few days before session starts.
The event is free of charge.
Stay positive, healthy and we all look forwards see you at the workshop!