Medical Device - Technical Documentation structure

#1
Hi everyone,

I am currently developping regulatory affairs strategy in my company for manufacturing of medical devices.
As an important part of this strategy, there is the Technical Dossier structure.
We are exploring different alternatives and one of these is the IMDRF/RPS WG/N9(Edition 3) FINAL:2019 - Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC)

Does anybody have experience with this TD structure? How is it considered by notified bodies for ISO13485 and CE (MDR) certification?

Thanks,
SImon
 
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