About us
Decades of FDA regulatory expertise, built on real-world outcomes
Regulatory Strategies Inc was founded by an industry veteran who has guided hundreds of medical device products through the FDA and CE Marking approval process.
Our mission
Regulatory Strategies Inc helps remove the uncertainty from FDA and International submissions. We combine device knowledge with practical regulatory experience to help our clients bring safe, effective products to market.
We believe that a clear strategy, rigorous preparation, and proactive FDA engagement are the foundations of every successful regulatory outcome. We have navigated the full spectrum of regulatory pathways — from early pre-submission meetings to post-market surveillance — and we bring that experience to every project.
Areas of expertise
The Team
Our founder brings decades of combined experience from FDA, industry, and clinical settings.
Gregory Mathison
Founder & Principal ConsultantGreg founded RSI in 1993 after 13 years in the medical device industry at Medtronic, Cardiac Pacemakers, American Medical Systems and Clarus Medical. He attained the Regulatory Affairs Certification (RAC) - Certificate #181 and served as Co-chair of the Medical Alley Regulatory Committee. He also was a past member of IAPM and EUCOMED. Greg has been a frequent presenter at Medical Alley, RAPS, MEDICA, Biomedical Focus and Medical Design & Manufacturing. Greg continues to focus on helping small start up companies who lead in medical device innovation navigate regulatory hurdles.
- PMA and International submissions
- FDA liaison strategy
Our Consultant Network
Supporting Specialists
- Biocompatibility
- PreClinical Testing
- Packaging
- Clinical Study Management
- Statistics
- Translation
- European Representative
Ready to move your product forward?
Give us a call