This 2-day advanced-level course will critically analyse the regulations covered in our 2-day introductory course Understanding the Medical Device Regulation by answering the following questions; what is the process, and what do I need to include to meet regulatory expectations?
These questions will be answered in the context of technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, post-market surveillance and post-market clinical follow-up studies.
In addition, this course will critically examine the Medical Device Regulation (MDR) by outlining the reasons for its development, the key regulatory updates to be aware of and what changes the industry must facilitate to ensure continuing compliance for their products.
Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.
Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.
He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.
He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.
He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).
This course is aimed at individuals who have prior knowledge of regulatory affairs for medical devices and are looking to apply this knowledge in a practical setting looking at life-cycle management.