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Whitepaper: How to Clear a Software Medical Device with the FDA

How to Clear a Software Medical Device with the FDA

This whitepaper discusses the standards and requirements needed for a successful FDA submission and clearance for a software medical device, and also defines pre-market v.s. post-market activities, submission timelines, CFR, XGMP, QMS, and DHF. It provides resources for businesses that help to ensure regulatory compliance and prevent unnecessary costs and delays.

How to Clear a Software Medical Device with the FDA

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Whitepaper: How to Clear a Software Medical Device with the FDA

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