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alexandrabuga replied to the topic The best strategy in running Risk Management Meeting in the forum Project Management Process and Medical Device Development 7 years, 2 months ago
If I were a PM running a Risk Management meeting, I would ask the attendees of the meeting to have them familiarize themselves with with the ISO 14971 standard as @aij5 mentioned, and for them (i) come up with a list of risks (ii) analyze the potential risks using Failure Mode Effects and Criticality Analysis (FMECA) and Process (PMECA) to look at; how it could fail, the severity of the consequences, and the probability that it will fail and also considering the detectability that if something goes wrong the probability you can detect it (iii) come up with solutions on how to manage the risk (avoidance, mitigation, acceptance, and transference)> I think then it would be a productive meeting to see if people came up with the same/different lists, evaluations, and ways to manage these risks.