Inquiry for missed document

Our ISO 13485 Documentation toolkit is in compliance with all requirements from ISO 13485. FDA revealed plans to harmonize its CFR 21 with ISO 13485 in 2018. Due to the Corona pandemic, this process has been a little bit delayed, but it is expected to be solved soon.

For more information see this link: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0910-AH99

Considering the EU MDR 2017/745; there are some more documented requirements for QMS (stated in Article 10) as part of our ISO 13485 & MDR toolkit.

For more detail on this topic, please see following article:

• List of worldwide regulations that require implementation of ISO 1348 https://advisera.com/13485academy/blog/2021/03/09/list-of-worldwide-regulations-that-require-implementation-of-iso-13485/