Regulatory Medical Device PMA Plans

[Sarah C]

Does anyone know where I can find a good example of a Class III medical device regulatory plan or timeline? I have a decent outline for the plan, but am having difficulty constructing a timeline from start to PMA approval.
Thank you!

 

[Ronen E]

In general project management, the principle method to cope with timeline uncertainty is to break down bigger work packages into smaller ones. Once you've done that, you'd be able to narrow down your uncertainty to a smaller number of more specific activities (while the majority will already be sorted). Then you could come back here and ask specific questions.
I don't think you'll find a fully detailed plan that will suit your own specific case. PMA approval can vary quite a lot, depending on the specifics.
Alternatively, you may elect to pay someone who's gone through the process multiple times and is able to provide estimates based on experience. Maybe @Watchcat could help you with that. My own experience with PMA is limited.

 

[Watchcat]

It depends.

What is the starting point for your plan and what are the key milestones that lie between the start and PMA approval?