That's the catchy blog title I picked for Jon Speer's recent blog post: "ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements", http://blog.greenlight.guru/iso-13485-medical-device-qms?utm_content=27240102&utm_medium=social&utm_source=linkedin. Why the title "Design Great Products"? First, most startups I meet are intimidated by the regulations, or want to indulge in wishful thinking. Second, if you read the regulations and follow their intent in your own system, what you'll find is a system that ensures vital design information is captured and flows from users, to the team, and to investors.
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