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.+undefined Other Responses
Fda 510(k) Guidance
I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device.
My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds.
Thank you.+3 Other Responses
Medical Device Manufacturing
we are starting a medical device company related to ivd (its a blood glucose monitoring wearable). We want to make sure to do the right things from the beginning. We would request your quote and timeline on all the following:
1. 510k submission for our class ii - we want someone who can guide on 510k, write the submission, correspond with the fda and get clearance for us.
2. Quality systems- write all sops for us per the fda, train our employees on all the sops
3. R&d - write testing protocols for us, write reports for all performance/bench testing.
4. Create technical file, assist in audit and help in getting ce mark.
5. Finding the right test labs for us and managing test labs.
Please advise how much would it cost for each of the above individually. We personally prefer fixed price projects.
Looking forward to working with you
ronen+29 Other Responses