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.
Mika has a Master's degrees in Law (university of Nice, France) and business administration (Wharton)
He has more than 30 years experience managing European medical regulatory affairs in industry, as 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 1990's
He is currently a member of various medical device expert working groups of the European Commission and 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: