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Tag: European Union

European Union Medical Device Regulation (EU MDR) and Risk Management — Reduce, Eliminate, Minimize, Remove or Avoid Risk?

Posted on 7 June 2021 (14 June 2021) by tim
Risk Management

Learn about the updated EU MDR’s strong emphasis on safety and risk management.

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Posted in medical device, regulations, risk management, UncategorizedTagged EU MDR, European Union, medical device, regulation, risk, risk management

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 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
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