We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.+14 Other Responses
Hi! we need a pre-submission to define the regulatory strategy for an innovative yet simple electrical non invasive medical device serving an under served population of patients. I understand that you might need more details, but i just want to check if the pricing is within our budget. Please let me know what will be your ballpark quote (or price range) and timeline for the following. If your price range is within our budget, i will contact you to move forward with the project.
1. Advising on what things will be needed for preparing a pre-submission.
2. Preparing all sections of the pre-submission.
3. Corresponding with the fda and answering all questions on the pre-submission.
4. Scheduling a meeting with the fda and discussing questions that need to be clarified to clearly define the regulatory strategy (eap/denovo/pma, etc).
5. Creating a final report for lir on regulatory path and testing needed, moving forward, based on the discussion with the fda.
Also if we need a 510k. What are the typical timeline and rates for a 510k? Thanks a lot! sumi+15 Other Responses