Twelve-step transition process from ISO 13485:2003 to 2016 revision
This white paper is intended for companies that have implemented the ISO 13485:2003 revision, and are planning to transition to the 2016 revision. The paper describes the suggested steps in the process.
Checklist of Mandatory Documentation Required by ISO 13485:2016
This white paper lists all the mandatory documents and records, and also briefly describes how to structure each document. It gives a perfect overview of your ISO 13485:2016 QMS.
ISO 13485:2003 vs. 2016 Conversion Tool
This free tool will help you to convert ISO 13485:2003 clauses to the new ISO 13485:2016 clauses. Just select the number of your current clause and find out what kind of changes you need to perform.