If I was a PM running a Risk Management meeting, I would, as most mentioned above, get everyone attending the meeting to be familiar with ISO 14971. I would start by getting everyone to identify the possible risks. The next step would be to evaluate and address these risk. We would speak about the risk that may be possibly present throughout the whole life of this product. This would include inventory management, surgical team set-ups, the patients who will use the product, and the caregivers who will administer the products. It is important that we speak about every risk that is possible from the beginning of the product to the very end.