ISO 13485 & EU MDR Integrated Documentation Toolkit

In my opinion, our ISO 13485 & EU MDR Integrated Documentation Toolkit is beneficial when compared to CEN/TR 17223 because in it we have already prepared procedures and templates for all documented requirements from the MDR 2017/745. We have focused on the general obligations of the manufacturer (Article 10) and the conformity assessment requirements (Annexes IX and XI), the same as in CEN/TR 17223. 

For the preview on the toolkit, please use the following link: 

ISO 13485 & MDR Integrated Documentation Toolkit https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/