Risk Management is an important but difficult concept for lots of industries, but is particularly important within the medical field and hence within medical devices. In such a hazard-rich industry, risk must be considered from the beginning to the very end of a product lifecycle. Implementing risk has never been more challenging, as recent regulatory changes have made it problematic to harmonize risk management processes in product lifecycles. Therefore, it is imperative to understand how to coordinate an effective risk management strategy.
This interactive course offers a comprehensive overview of the regulatory requirements for risk management and provides an insight into a variety of tools and techniques to implement them into your own systems. Attendees will be provided with an in-depth outlook on EN ISO 1497 and its overlap with ISO 13485 and the new MDR, alongside gaining an informed insight into the intricacies of risk management planning. Overall, attendees will expect to be taken through the risk management process from start to finish.
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 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.