Scott Cook
Vice President of Quality and Compliance

It has been 13 years since we have seen significant changes to ISO 13485 in the medical device industry. The new ISO 13485-2016 impacts many areas of the quality management system, and the differences may take more time to transition for medical device manufactures and medical device contract manufacturers than you think. There are, of course, a number of clarifications that will strengthen the quality management systems of finished medical device manufacturers; like validation, verification and design activities. Other revisions include harmonization of regulatory requirements, increased focus on feedback mechanisms and stronger supplier control processes. The key area to focus on is risk analysis and risk management as it relates to the quality management system. This may be more of a challenge, as this approach is quite different from the current ISO 13485-2003 process approach.

At the end of the day a thorough gap analysis is recommended to provide a baseline of significant changes to be addressed. We have 3 years to transition to the new ISO 13485-2016, but why wait? Start your gap analysis now for a smooth and seamless transition.