Medical Device
Consulting
Specialized 510(k) regulatory consulting strategy development and submission assistance for the next generation of medical device innovators.
Get StartedCore Competencies
FDA 510(k) Submissions
Predicate/Reference Device Strategy
eSTAR Preparation
Pre-Submission (Q-Sub) Submissions
Technical Performance Data Review
Technical File Considerations
510(k)
eSTAR
Class II
Q-Sub