Title: Module 8 Additional Resources
Course: PW-Course-Import-Test > Section: Module 8: ISO 13485

Module 8

Read

Review the Comparison between FDA QSR and ISO 13485

Compare ISO 13485 and FDA-QSR-21CFR-820 which describes several reasons why the FDA has not harmonized with ISO 13485 (adopted).

White Paper: Comparison of Medical Device Standards & Regulations ISO 13485:2003 & US FDA 21 CFR part 820 that also provides details about the differences between the ISO Standard and the QSR.

ISO Take Away Notes