Course Outline Risk management is ever-more important for medical device companies, and it’s a complex process. EN ISO 14971 enables companies to integrate risk management into their existing quality systems and provides a disciplined approach for decision-making and implementation of strategy in this area. The latest version of the standard has given device manufacturers significant challenges in terms of meeting revised harmonisation annexes, and may require them to modify their approach. This practical course provides delegates with the tools and techniques to understand and apply EN ISO 14971 – not just those new to the area, but those who want an update on the latest annexes to the standard (annexes ZA, ZB and ZC). It shows you how to integrate risk management and EN ISO 14971 into your own organisation, and enhance your existing quality systems. You will also learn how to modify your approach – including how to upgrade existing files to comply with the latest version, EN ISO 14971:2012, harmonised to the Medical Device Directives as well as essential requirements relevant to Risk Management from the new Medical Device Regulation.
EN ISO 14971