Should you be interested, we offer you a confidential agreement to protect your proprietary and intellectual disclosure. We will present a performance contract specific to your project.
Our references will answer these questions
1) Does C2 perform as C2 say they will?2) Do they do what they say?
3) Are C2's predictions accurate (about FDA requirements and reactions)?
4) Are C2 's predictions accurate (short & long term)?
5) Did C2 spend the necessary time and effort to support their performance claims?
6) Did any plan that was proposed by C2 place you in any uncalculated risk or jeopardy?
7) Was any of C2's advice overturned by the FDA or was any of their advice revealed to be flawed?
8) Did C2 ever have to defer questions to others or did they deal and solve issues?
In our first conversation (Phase One), we will give you
an preliminary cost for our services to create a 510(k)
based on these responses....
9) Did C2 offer vital improvements that improved your FDA application and reduce risk?
10) Comparatively - was C2's fee expensive?
11) Was C2 worth their fee?
12) Was C2 always truthful from your first contact?
- Unit selling price (rough order of magnitude)
- Distribution network (distributor, direct)
- Market competition (predicates)
- Development budget (rough order of magnitude)
- Patent & IP positions
- Product launch schedule (rough order of magnitude)
- Stated performance of the medical product
- Who would purchase the device, to whom would the device benefit (patient)
- What patient/marketplace will device compete in?
9) Did C2 offer vital improvements that improved your FDA application and reduce risk?
10) Comparatively - was C2's fee expensive?
11) Was C2 worth their fee?
12) Was C2 always truthful from your first contact?
