I have a newly founded company. Prenatal Hope Inc. I could use help in moving our product through development, clinical, and FDA approval. If anyone would be willing to offer advice, templates, etc. I would greatly appreciate it. This product will have a tremendous positive impact on maternal and fetal health. Saving Changes...
I think you might have difficulty getting much useful advice because your question is overly broad. Medical devices include everything from bandages to The Machine That Goes PING, and you're asking for "cradle to grave" project advice. That is a tall order, as it's literally my full time job in another highly regulated industry.
I can offer some lifecycle selection advice however. You are dealing with a highly regulated field and (potentially) highly complex hardware solutions. To me that would suggest the design development would employ a systems engineering (systems theory, not IT systems) predictive development model. (The SE "Vee") You at least need to identify your critical functions and requirements up-front so that you have an understanding of your certification plan. You may be able to do iterative design in an agile fashion during some project phases, but that depends a lot on the product itself and your design tools available for things like prototyping. If it is a complex system, your SE (or equivalent) and PM should be working hand-in-hand if they're not the same person.
Since this is a PM forum rather than a SE forum, I would say that the project plan will be heavily dependent on the product development plan or SEMP (S.E. Mgmt. Plan). The art of the possible in terms of design and verification will heavily dictate the PM plan for the execution.
At the heart of the plan will be the product functional architecture (what the thing does), and the requirements traceability matrix. Those will dictate the WBS, certification approach/plan, scheduling approach, risk management plan, and other critical elements of your overall PM plan. Saving Changes...
