EU ISO 13485:2016 Medical Device Quality Management System
: 24 Nov 2020
This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).
The EU's Notified-bodies mandate to get tougher across the board in their expectations for the medical products industry and its compliance with the standards/regulations will be discussed. This webinar will examine the changing focus of medical device regulation, similarities, and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs). We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU. Also considered are multi-site company operations, and the supply chain; trends evident in regulatory inspections; and recent major industry failures.