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Design Controls - Requirements for Medical Device Developers
Рет қаралды 30,829
Күн бұрынThe FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" - "fast cycle" product development.
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@carol_hyejinkim 5 ай бұрын
Great webinar. Thank you😊
@CityWalkSHA Жыл бұрын
Still a very good training material today! Thank you!
@imcintertech2066 4 жыл бұрын
Nice video! Thanks for sharing!
@kevinjones8488 5 жыл бұрын
Great presentation! Thank you!
@TeW33zy 2 жыл бұрын
Didn't even understand half the words? What is the document he said download. I couldn't make out the word cusid?
@daltonymd8391 2 жыл бұрын
sterilization is definitely design output, biocompatibility aswell
@paragkale5459 2 жыл бұрын
nice
@TeW33zy 2 жыл бұрын
What is cusid?
@jlak892 2 жыл бұрын
It's QSIT- Quality System Inspection Technique. Google for examples.
@TeW33zy 5 жыл бұрын
Dude before u post a video get your damn audio fixed that's crazy. People will post trash just to post
@purpohpenguin 4 жыл бұрын
Keep in mind this is a 6.5 year old video, not the newest of microphone technologies Im sure.
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