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Hi,
I'm a student in a Regulatory Affairs course. I could use your insight. I know this will initially be very broad, as I don't know enough on the subject to refine yet. But I hope the group could help guide me on this learning journey.
In a scenario where you are first meeting with a project team (marketing, engineers, etc) and they provide a wish list for what they envision a new product to be (and of course want it to do everything, have fantastical claims they want to make, launch fast, and be new and innovative)... How do you start digging through this to provide guidance to the team so that they don't overreach? With the goal to keep the product in a 510k submission process?
Are there any guidances or checklists to help with best practices in determining med device product classification between a Class 2 and 3 device, claims, project checklist, or just guidance on what points could be used to question the team and refine direction for realistic project planning?
I'm a student in a Regulatory Affairs course. I could use your insight. I know this will initially be very broad, as I don't know enough on the subject to refine yet. But I hope the group could help guide me on this learning journey.
In a scenario where you are first meeting with a project team (marketing, engineers, etc) and they provide a wish list for what they envision a new product to be (and of course want it to do everything, have fantastical claims they want to make, launch fast, and be new and innovative)... How do you start digging through this to provide guidance to the team so that they don't overreach? With the goal to keep the product in a 510k submission process?
Are there any guidances or checklists to help with best practices in determining med device product classification between a Class 2 and 3 device, claims, project checklist, or just guidance on what points could be used to question the team and refine direction for realistic project planning?