A anonymous16 Dec 27, 2017 #1 Dec 27, 2017 #1 Hello! What are the differences between the two? What is changing? Does anyone have a "gap analysis" showing the difference between them?
Hello! What are the differences between the two? What is changing? Does anyone have a "gap analysis" showing the difference between them?
Sidney Vianna Post Responsibly Staff member Admin Dec 27, 2017 #2 Dec 27, 2017 #2 The ISO 13485:2016 Gap Analysis with Changes Identified thread should give you pretty good insight. Good luck.
The ISO 13485:2016 Gap Analysis with Changes Identified thread should give you pretty good insight. Good luck.