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1:25
YouTube
Rook Quality Systems
What Is a PCCP? #samd #fda #medtech
What is a Predetermined Change Control Plan, and why does it matter for SaMD teams? Andrew Wu, VP of Medical Software at Rook Quality Systems, breaks down how a PCCP lets you iterate your AI-enabled device without filing a new 510(k) every time, and how planning it right becomes a competitive advantage. Subscribe for more regulatory insights ...
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3 weeks ago
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