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Terms and Definitions Matter
Terms and definitions matter to the FDA, and they should matter to you. Common terms and definitions improve communication and understanding. In the new Quality Management System Regulation (QMSR), the FDA referenced ISO 9000:2015 and ISO 13485:2016 for definitions. They have also defined some terms and definitions that supersede those. It is a bit confusing, so we did the hard work for you. We created a consolidated glossary of terms and definitions for medical device companies.
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