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Design Controls - Requirements for Medical Device Developers 

GlobalCompliance Panel
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The 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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21 окт 2024

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Комментарии : 11   
@carol_hyejinkim
@carol_hyejinkim 7 месяцев назад
Great webinar. Thank you😊
@CityWalkSHA
@CityWalkSHA Год назад
Still a very good training material today! Thank you!
@imcintertech2066
@imcintertech2066 4 года назад
Nice video! Thanks for sharing!
@TeW33zy
@TeW33zy 2 года назад
Didn't even understand half the words? What is the document he said download. I couldn't make out the word cusid?
@kevinjones8488
@kevinjones8488 5 лет назад
Great presentation! Thank you!
@daltonymd8391
@daltonymd8391 2 года назад
sterilization is definitely design output, biocompatibility aswell
@TeW33zy
@TeW33zy 2 года назад
What is cusid?
@jlak892
@jlak892 2 года назад
It's QSIT- Quality System Inspection Technique. Google for examples.
@paragkale5459
@paragkale5459 2 года назад
nice
@TeW33zy
@TeW33zy 5 лет назад
Dude before u post a video get your damn audio fixed that's crazy. People will post trash just to post
@purpohpenguin
@purpohpenguin 5 лет назад
Keep in mind this is a 6.5 year old video, not the newest of microphone technologies Im sure.
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