ISO 13485:2016 – What’s Different?

This file, actually a set of Power Point Slides, is from a presentation made by Ron at the 16th Annual Product Complaints Congress for Life Sciences, June 2018, Alexandria, VA.   In this presentation, Ron outlines the critical changes to the 2016 version of the ISO 13485 medical device standard, the documents required, integrating this standard into your QMS with the FDA regulations for medical devices, how risk-based approach applies, and how to integrate your business processes and the standard.  This review also takes a look at post market surveillance activities required of the standard.

Click here to view all of the presentations made at this conference

Questions and comments are welcomed!


The ISO 13485:2016 Transition Journey

Here is a relevant and timely article regarding the status of the transition to ISO 13485:2016.  This article, written by Jim Shore, Chair-elect, ASQ Biomedical Division, published in June 2018 edition of MPO (Medical Products Outsourcing), provides the results of a survey conducted of 150 medical device professionals in March of this year.  A significant take-away from this survey is the data indicating 44% and 37% of the respondents noting that challenges to reaching their goal is due to insufficient resources and  updating procedures, respectfully, is a major reason.