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Parth D. Patel replied to the topic The best strategy in running Risk Management Meeting in the forum Project Management Process and Medical Device Development 7 years, 5 months ago
If I was running a risk management meeting, the first thing I would do is ask the team to review IS0 14971, because it is basically the bread and butter for risk analysis for medical devices. I would have a meeting to assess the the risk/hazards with the project team and other project managers, depending on how big this project is. As the leader of the meeting I would also bring awareness of the current risk statements if there are any, and ask the team to bring any new ideas for any the potential risk or hazard before the meeting(s). In the meeting, instead of identifying the risk or hazard and listing them, our goal would be to define the risk, by finding any cause and effect. Some questions that need to be brought up are, Why should this potential risk or hazard be considered? What is the cause of this issue, and is there any way to fix it? I would also go over a rating system. Which risk or hazards are critical or major, and which ones are minor.