I agree with you ks629. The Project Management Process Groups are all valid processes for the different management groups. What is important as Dr. Simon said is the Project Communications Management Group. This group is an integral part of medical device development. You need to have a clear and concise plan set in place of how communication between management and process groups will be established. We know each process group is intertwined but is separate from the different management sectors. Therefore, a clear and concise plan of action needs to be done to have effective communication. For example say you have a FDA regulator affairs individual for your company they are probably speaking to the Project Manager of the project which will relay the info to the Initiation Process Group and the Manager of Project Communications. The Communications manager needs to identify the various stakeholders to reach out to for the project to start. The project manager can evaluate it and state the decision to initiation group to either say “yes” or “no”.