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 […]
My goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project. In my experience, dealing with the fires of the day always take precedent over managing things that […]
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 […]