My company uses many of the tools mentioned above to identify and manage risk. As the professor also mentioned, risk can be associated with the design as well as the manufacturing of the device. Risk can also just be associated with the way that the device will be used. From a functional standpoint, the QA department conducts a functional analysis where they look at each individual step in the surgical procedure and identify any risks that exist. A risk table is then generated as an output of the functional analysis. From a design standpoint, QA reviews the engineering drawings with R&D to identify any critical quality attributes (CQA) related to the design. We also perform dFMEAs to identify failure modes and their effects related to the design and we work with our suppliers to conduct pFMEAs where we identify failure modes and effects of all process (manufacturing) related activities. So I would say we approach and identify risks at many different angles in my company.