On May 31, Paul Theunissen will give a regulatory workshop at the Netherlands Institute for Neuroscience.
Workshop: Turning Research ideas into Medical devices
In this workshop, the route from a research prototype to a certified medical device is discussed. The workshop is intended for both technical and clinical staff. The workshop is interesting for staff involved in neurotech research studies as well as medical device start-ups. The workshop will be interactive with sufficient room for discussion, cases and many practical examples. As an example, some of the topics that will be covered:
Medical device regulatory landscape
When is a device a medical device?
When is my study regarded as a clinical investigation?
What is the MDR and do I need to involve a notified body?
Who is responsible for a medical device in the market?
Device documentation
What is the minimum content of a CE Technical file?
What are product requirements, verification and validation?
What is the role of risk management?
Do I need to use standards? (IEC, ISO, ...)
Quality systems
Do I need a quality system?
Does it need to be certified? (e.g. ISO13485)
Can I start with a small quality system and extent it during development?
About the host
The workshop will be given by Paul Theunissen. After 10 years working in product development, in 2005 Paul accidentally became involved in ‘regulatory affairs’ and since then supports medical device startups with getting medical devices to the market.
For more information about this workshop, you can contact Samantha Wolff (This email address is being protected from spambots. You need JavaScript enabled to view it.)
Date: May 31, 2022 - 14:00-17:30h.
This workshop can only be attended in-person (max. 12 people). Costs are €15.