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Project Management in FDA Regulated Industries

I just finished the Project Management Course.  It provides a very good framework of the main process (Define, Plan, Execute, Monitor and Control, and Close); however, working for medical devices companies made me realize that we might need to fine tune the process to better fit the regulated environments.  Do you think that the process of Define, Plan, Prototype, Test, Monitor, and Iterate will better meet the needs of the regulated industries?

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