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!