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Category: Uncategorized

Medical Device Regulations Part 1 — USA

Posted on 18 January 2021 (25 January 2021) by tim
FDA Sign

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 regulations, UncategorizedTagged 21 CFR part 820, FDA, GMP, medical devices, regulations, USA

Medical Device Regulations Part 2 — Europe

Posted on 18 January 2021 (25 January 2021) by tim
EU Medical Device Regulation

An introduction to The European Union Medical Device Regulation (EU MDR) 2017/745, CE certificates and the companion standard European Union Invitro Diagnostic Regulation (EU IVDR) 2017/746.

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Posted in regulations, UncategorizedTagged EU IVDR, EU MDR, European Union, medical devices, regulations
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Recent Posts

  • Medical Device Regulations Part 1 — USA
  • Medical Device Regulations Part 2 — Europe
  • Brief History of Medical Devices and Regulations

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