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ISO 13485:2016 Blog

An Analysis of ISO 13485:2016 and the Impact on Medical Device Organizations

The sky is FALLING!

...or is it?

You know how it is with RA/QA professionals and worse yet, CONSULTANTS!  Get three together in a room and you have seven opinions - but only if two of them are bound and gagged. As I'm out and about working with my clients and interacting with my colleagues, I'm finding that, while there is general consensus on what is new and what has changed with the ISO 13485:2016 standard, the impact on any given device manufacturer varies greatly - particularly if they've not had much exposure as a finished device manufacturer.  There are a couple of subtle changes that, if not properly interpreted, may result in unnecessary work.  Alternately, some changes, if not assessed properly, might result in shock and awe come upgrade time.  

Every couple of days, I'll review a clause of the new standard and will provide an analysis of what's added, what's removed and what it means to the small to mid-sized manufacturer.  I'll provide implementation tips and will discuss potential pitfalls.  

There are lots of opinions out there. I want to hear yours.  I bring to the discussion over 25 years of device experience, successful implementation and maintenance of dozens of Quality Management Systems, and training to the new standard from one of the most respected medical device registrars.  I welcome your comments and feedback.

We're in this together!