Haroon Atchia, Technical Director and Chief Executive Officer of QFI, will give an overview of the concept of risk management for combination products and discuss risk management strategies, risk analysis and common pitfalls to avoid when introducing a combination product. The discussion includes the obligations prescribed in the various European medical devices Directives, invoked Directives, Regulations and Decisions, demands of particular Standards and the concomitant duty-of-care expected of manufacturers. Further, application of relevant Standards is expanded to include relevant principles and practice, application of safety and reliability engineering techniques, inter alia.
