Confidence Beyond Compliance

Pre-Market RA:  From Product Development to Market Authorization

Our services include regulatory strategy development, predicate device searching, pre-submission support, clinical study support/SAE-UADE Management, submission preparation and support for regulatory agency interactions/communications to assist our clients’ with getting their products to market.

Post-Market RA:  After Product Market Authorization

Our services include on-going regulatory maintenance activities such as labeling, technical file and CER updates as well as post-market surveillance, performance analysis/reporting and assessment of design changes as products continue to evolve and improve overall healthcare.

Regulatory Affairs Consulting for Medical Devices