November 18, 2020

Medical Device Manufacturers Transitioning to ISO 14971:2019 Need to Perform a Gap Analysis and Create a Cross-Functional Risk Management Team

Author: Nupur Srivastava, PhD  | November 18, 2020

There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019,  and experts agree that medical device manufacturers need to perform a gap analysis and create a cross-functional team to meet these risk management requirements.  

Risk management plays a critical role in getting medical devices into the market, and ISO 14971:2019 “was designed to better align with medical device regulations around the world.” The global regulatory landscape has been very dynamic around the areas of risk management, as well as safety and performance. 

Tips on Putting Risk Management into Quality Systems During the Transition to ISO 14971:2019 

Two experts shared insights during an interview with Medtech Insight. Jos Van Vroonhoven, convener of ISO Technical Committee 210, Joint Working Group 1 (TC210/JWG1) and a senior manager for standardization for device giant Philips Healthcare, and Don Powers, a member of ISO TC210/JWG1 and long-time industry expert, said that the third edition of ISO 14971 provides more precise guidance and greater detail in the application of risk management concepts.  

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