RISK MANAGEMENT STANDARD FOR MEDICAL PRODUCTS. WHICH WAY IS THE WIND BLOWING? -- MEDICA - World Forum for Medicine

09.11.2020

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RISK MANAGEMENT STANDARD FOR MEDICAL PRODUCTS. WHICH WAY IS THE WIND BLOWING?

Seeing which way the wind is blowing means being able to recognise developments and adapt to necessary changes. ISO 14971:2019, the risk management standard for medical devices, published in its third version in December 2019, is a good opportunity to see what has happened since then. First things first: The risk management standard for medical devices ISO 14971:2019 has not yet been harmonised for MDR, but there is an up-to-date guide for its implementation.

seleon's experts summarise the most important points of the guide and from an MDR perspective for the risk management standard ISO 14971:2019-12 and point out discrepancies in harmonisation in their Regulatory Affairs Blog.

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