Hello, i'm looking for a consultant to assist with an fda 510k submission for a:
class ii ophthalmic medical device
if you have expertise in this area, please let me know. Thank you.+24 Other Responses
Medical Device 510k
We are a contract manufacturing company. We have a medical device manufacturing license from the state of california. We manufacture private label personal lubricants that now require 510k approval by the fda. Our customer that we manufacture the lubricants for has gotten 510k approval on his product, but that is only for his brand. As a contract manufacturer we must get 510k approval on our formula and list what brands we produce it under. I need a consultant that has 510k experiences.+35 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
A pma submission expert for a submission of a new cosmetic filler similar to radiesse that could possibly be combined with a lidocaine for pain management and would be delivered with thawed cryo-preserved amniotic allograft component that is mixed once in a liquid format state. The expert must be willing to testify in court.+8 Other Responses