Lean Entries Blog - May 2017

Requirement UX: Tables of Contents for the new Medical Device Regulations in EU

Dear Reader, If you need Tables of Contents for the new European Medical Device Regulations, like we do, please download them from here:  Table of Contents - Medical Device Regulation (MDR) 2017/745 Table of Contents - In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 The Tables include links to the regulations, as published in their…

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Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

Dear Reader, Years ago I worked for a medical device startup whose ambitions were bold and respectable. Their aim was to bring back at least some muscle movement for those who have been paralyzed. But it was a tough nut to crack. Even if we could've developed the technology, the regulations and standards didn't bend…

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