As a medical device or IVD manufacturer, it is imperative to ensure you are employing up-to-date procedures for post market surveillance to guarantee regulatory compliance and avoid product recall. This course will provide you with the latest updates on regulations for medical device and IVD PMS and vigilance, clarifying any grey areas to outline your responsibilities as the manufacturer.
Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to build successful PMS strategies and understand the latest requirements and technologies for reporting vigilance. Delegates will also be provided with additional time 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 relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:
The interaction with the trainer and other participants with a focus on practical exercises was very useful.
The depth of knowledge of the presenter and breadth covered in the course was excellent.
I enjoyed all the examples given during the presentation as well as the vigilance content and information/experience shared between attendees.