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
Exhibitor Data Sheet