The second phase of our 510(k) is to meet with you to discover the
project issues. We work with your people at every skill level from the
board room to the shipping dock and all the labs and production stations
in between. We investigate the product and product claims.
We review your existing documents and measure the issues necessary to achieve a successful determination of substantial equivalence with the FDA / CDRH. From that analysis, we formulate the issues and form a framework of the application. The documents required emerge from this. Only after the review is completed can we determine the documentation system describes the product and is base lined for the application.
We review your existing documents and measure the issues necessary to achieve a successful determination of substantial equivalence with the FDA / CDRH. From that analysis, we formulate the issues and form a framework of the application. The documents required emerge from this. Only after the review is completed can we determine the documentation system describes the product and is base lined for the application.
What you should be confused about ...when you call us...
- Unit selling price (rough order of magnitude)
- Proposed distribution network
- Market competition (predicates)
- Your overall budget including
- Patent & IP position
- Product launch schedule
- Stated performance of the product
- What patient/marketplace will your device compete in?
