Risk Management

Posts tagged with “Risk Management”

Christian Fleischhacker

MPO: PFMEA, ISO 14971, or Both for Medical Devices?

The September 6, 2023 online issue of Medical Product Outsourcing (MPO) features online exclusive, PFMEA, ISO 14971, or Both for Medical Devices, written by Dana Trousil, StarFish Mechanical Engineering Team Lead. Trousil is concerned with the questions whether the risk management tool PFMEA (Process Failure Modes and Effects Analysis) and how it fits into the development […]

Mike Camplin

BoneZone Journal: Risk Management Under ISO and MDR

  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 […]

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