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Tag: USA

Medical Device Regulations Part 1 — USA

Posted on 18 January 2021 (17 April 2021) by tim
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Since 1906, the US FDA has sought to ensure the safety and efficacy of medical devices. This article outlines the history and rationale that created the Quality System Regulation for Medical Devices 21 CFR Parts 820.

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Posted in medical device, regulationsTagged 21 CFR part 820, FDA, GMP, medical devices, regulations, USA
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