We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.
Dov |Director, VP
What is the commitment in terms of hours and travel? My availability is limited to a few hours a we...2 Hours Later
Hrishikesh |VP of R&D and Manufacturing
I would be more than happy to be the "hands-on doer". I have been through two De Novo submissions re...2 Hours Later
Susan |President and Founder
I have over 20 years experience and have submitted many 510ks. The largest was 8000 pages and I am e...2.3 Hours Later