FDA 510(k) Support
We have worked with many clients to assist them in entering the US market through the swift and cost-effective acquisition of a successful FDA 510(k) submission.
The FDA 510(k) is a notification submitted to the FDA to demonstrate your device(s) safety and efficacy.
We use a proven four-step process to ensure your successful FDA 510(k) submission:
Pre-submission Gap Analysis
Evaluation of Requirements
FDA Quality System Regulation (QSR) 21 CFR 820 Services
If you wish to sell your medical or in-vitro diagnostic device into the US market you will first need to have a Quality Management System (QMS) (which is like the ISO13485 standard) that meets the FDA’s Quality System Regulation (QSR).
We will work with your business to provide you with a bespoke QMS which is fully complaint with the FDA QSR.
We have many years’ experience working with clients to determine the proper classification for your device in the US.
Using the FDA classification data base we can help you classify your device effectively and if this is not possible (we will assist in a novel or ‘de novo’ submission
FDA Warning Letter or Form 483 Remediation
We are able to help you in the preparation of an effective response to an FDA Warning Letter (or Form 483) including an analysis of the findings in the letter, propose suitable timeline, suggest and assist in the implementation of Corrective Actions and also we can be available to answer both the FDA’s and your queries as we work together to correct the violations or deficiencies.