Experienced • Effective • Affordable
Clients get better results through outsourcing - FDA 510k submissions, procedure writing, validations, internal auditing, employee training, complaint handling (MDR), and CAPA projects.
Knowledge and experience is a significant advantage when submitting a 510(k) application. We make it easy for the reviewer to say "YES". The longer a FDA 510k submission drags out the more sales are delayed or lost. We work hard to assure your new product hits the market without delay and with the right claims. Our low overhead structure allows us to offer exceptional value. Clients have the choice of a flat rate fee for our 510(k) submission services or paying by the hour. Unlimited phone and email support. Experience - we have been working with 510 k submissions since the FDA started regulating medical devices (1976).
Our process:
1. Collect the required data from our client using our simple to understand data collection forms.
2. We research the applicable FDA regulations, guidance documents and previously filed 510(k) documents. This research is a key component to a prompt release to market.
3. Verify that the predicate device claims are consistent with the claims for the product.
4. Prepare the 510(k) for final review and signature by our client, most 510(k) premarket notifications are between 50 and 250 pages.
5. Submit the 510(k) to the FDA.
6. Maintain a dialog with the FDA reviewer to:
a. obtain clarification regarding reviewer questions,
b. reconcile any issues cited by a reviewer during a review cycle,
c. inquire whether a new timeframe may be given to provide addition information requested during a review cycle because the initial timeframe cannot be met,
d. discuss procedural questions related to the submission, or
e. request or schedule a meeting with the FDA.
7. Prepare a response if the FDA has questions or requires additional information.
8. Provide phone consultation to our client and the FDA 510k reviewer throughout the process.
For a free consultation call
Washington, DC 1-202-241-3407
Chapel Hill, NC 1-919-942-1634