Solutions

Regulatory Strategy Assessment
‍Clarify whether or not your tech is considered a device; which device it is classified as; which U.S. FDA regulation it is under; which performance, bench, or biocompatibility tests are required; and the best regulatory strategy to receive U.S. market authorization.

Compile Expert Team and Resources
Due to the vast number of device types, technologies, and regulatory requirements, we need to compile the right expertise and resources to match your specific needs.

Plan and Engage Regulatory Agency Early
Engage FDA to resolve potential unanswered questions on clinical trial endpoints, sample size power requirements, or about performance testing to satisfy safety and effectiveness requirements.

Ensure Required Testing is Satisfactory
We will ensure all your required testing is satisfactory and that the feedback received from the FDA has been resolved.

Compile & Submit Regulatory Package for Formal Review
Only after your file passes our internal audit, will we then formally submit it to the FDA for formal review.

Actively Manage File Under Review
Most lead reviewers at the Agency will have outstanding questions on your file. These will need to be resolved and are commonly referred to as deficiencies. If they are within reason, the Agency provides the opportunity to resolve them interactively during the review.