Episode Details

This is the audio-only version of DEVICE LOVE Live! #25, originally recorded 17 December 2020.

ISO 14971:2019 is not yet harmonized to the EU MDR/IVDR, however, BSI has declared that it is the state of the art and is issuing findings against it in MDR audits. Regardless, it is anticipated the 2019 revision will be harmonized to the regulations and therefore, we recommend manufacturers begin the transition.

In this DEVICE L❤️VE Live! show, our expert panelists will discuss the following and more:

What are the changes in the 2019 edition? What areas can you expect the notified bodies to focus on in audits? What are the topics of confusion or debate in the 2019 edition?

Please bring your questions to be answered real time by our experts, including former notified body representatives.

Ed Ball – Senior Associate, Maetrics Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Ron Sills – Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019) Michael Wolford – Senior Principal Specialist, R&Q Nicky Kranz, MHA – Senior Principal Specialist, Consulting Services

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