How to Approach Risk Management Under ISO and MDR Updates by Virginia Anastassova, StarFish Medical Regulatory Affairs Manager/Senior QA Specialist, is the ASK THE EXPERT feature in the March 2020 online and print editions of The Bonezone Journal. Anastassova’s article answers the question: How do I handle medical device risk management and the change from ALARP to AFAP?
She notes, “You must look no further than the newly issued ISO 14971 in December 2019 and the EU Medical Device Regulation (MDR) coming into force in May 2020 to realize that medical device risk management is an ever-evolving process. Staying current with the latest regulations, standards and guidance is key.”
ALARP is no longer mentioned in the MDR or the new ISO 14971:2019, and using ALARP is no longer acceptable. In the article Anastassova provides a summary of the most relevant changes in ISO 14971:2019.
Anastassova wraps up her advice with this message: “In conclusion, ISO 14971:2019 provides a thorough process for manufacturers to identify medical device hazards, assess risks, control risks and monitor the effectiveness of risk controls throughout the life of a device. The expectation is to reduce risk AFAP. This new edition, comprising 10 clauses and three annexes (informative), is aligned with the general safety and performance requirements within the new EU MDR; it is expected to become a European harmonized standard and therefore represents the current state of art.
BONEZONE is owned and produced by ORTHOWORLD®, a specialty publishing firm solely focused on the global orthopaedic market. BONEZONE launched in 2002 to an engaged readership of R&D engineers, supply chain managers and procurement professionals. By 2012, readership expanded to include executive management and quality, regulatory and clinical affairs professionals, with growing interest from marketing teams in light of pressures from Unique Device Identification (UDI) initiatives and Design for Manufacturability mandates.
About StarFish Medical
StarFish Medical is a full service Medical Device Design company offering design, development, and manufacturing services based in Toronto and Victoria. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System and an FDA registered manufacturing and clean room facility. www.starfishmedical.com
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