Regulatory Compliance Associates® strives to provide the highest healthcare consulting value possible. To that end, we determined that containing the costs for a 510(k) submission would be advantageous for our clients. Our Statement of Work for 510(k) Submission Services is now based on a reasonable, predetermined fixed fee. 510k
This structure will provide you with a high-quality, budget-friendly option, where RCA shares the risk in ensuring that your submission is completed in a timely manner. It will also include post-submission support through the FDA determination, which is critical in certifying that any AI (Additional Information) requests are handled in a timely manner.
Other benefits of working with RCA include:
- Superior service from our regulatory submission subject matter experts—our team has extensive FDA submission experience across a broad spectrum of medical devices.
- Efficient and effective submission process—our services are based on a firm understanding of the FDA’s expectations and requirements. By utilizing standardized and proven templates and formats, we are able to process your submission in a timely, efficient manner.
- One-Stop Shop—in addition to regulatory expertise, RCA can assist you with meeting the good manufacturing practice (GMP) part 820 requirements as required by the FDA for medical device manufacturers selling products in the U.S. market and/or ISO 13485 requirements for the global market.