Foreseeable Misuse of the New ISO 14971:2019 and EU MDR


Thursday, June 17 | 11:15 am - 12:00 pm


Room 49



Participant Type:

Product Development, Quality/Regulatory

Recent changes to ISO 14971 (ISO 14971:2019) and the release of the EU Medical Device Regulation (MDR/2017/745) have reshaped the requirements for risk management for medical device manufacturers. In this presentation, we will discuss the updates to ISO 14971 and the specific risk management requirements for MDR. We will then discuss implementation strategies and how the changes affect manufacturers. Finally, we will review the updated Technical Report ISO/TR 24971, which now contains many of the informative annexes from ISO 14971 and additional new annexes.

Learning Objectives

  • Awareness of the changes to ISO 14971:2019

  • Knowledge of MDR risk management requirements

  • Overview of an implementation strategy for adopting both, ISO 14971:2019 and MDR risk management requirements

  • Information on how to use ISO/TR 24971:2020


Rich Granquist

Quality Systems Consultant,