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Tag: medical devices

ISO 13485: The Global Quality Management Systems Standard for Medical Devices

Posted on 28 March 2021 (17 April 2021) by tim
ISO logo

With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.

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Posted in medical device, regulationsTagged European Union, ISO 13485, medical devices, regulations

Medical Device Regulations Part 1 — USA

Posted on 18 January 2021 (17 April 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 medical device, regulationsTagged 21 CFR part 820, FDA, GMP, medical devices, regulations, USA

Medical Device Regulations Part 2 — Europe

Posted on 18 January 2021 (17 April 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 medical device, regulationsTagged EU IVDR, EU MDR, European Union, medical devices, regulations

Brief History of Medical Devices and Regulations

Posted on 18 January 2021 (25 January 2021) by tim
Trepanation instruments, 18th century

Learn about that history of medical devices from ancient to modern times, and how regulations evolved in the mid-20th century to protect patients and ensure safe and effective medical devices.

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Posted in medical device, regulationsTagged history, medical devices, regulations
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