“Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”
Gap analysis MDR vs CFR 21
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
May 15, 2022
There are some differences between documentation. You can find it in the following article:
- FDA vs. EU MDR Technical Documentation Matrix - https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix
For any other questions, do not hesitate to contact us.
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May 15, 2022
May 15, 2022