Built on Decades of Hands-On FDA Experience
FDA RA Group was founded on a simple principle: medical device and IVD companies deserve consultants who have actually done the work — not just reviewed it.
FDA RA Group: More Than Advice
After more than 20 years in the medical device and life sciences industry, our founder continued to see the same problem across organizations of every size. Companies invested in consultants who delivered reports, recommendations, and presentations, but left internal teams to determine how to put that advice into practice. In some cases, the recommendations created additional confusion, introduced unnecessary complexity, or made existing compliance challenges worse.
FDA RA Group was founded to change that model.
Our team brings together trusted experts our founder has worked with throughout her career, including former FDA lead reviewers and experienced regulatory and quality professionals who understand how compliance functions in real organizations.
We do not evaluate your systems from a distance. We walk your facility, speak directly with the employees performing the work, observe how your procedures and systems are actually used, and identify the operational realities behind the documentation. We remain actively involved throughout the process, helping your team build, implement, and strengthen solutions that work in practice.
The result is more than a report or a list of recommendations. It is a clear, actionable path to regulatory readiness supported by people who understand your organization and are prepared to work alongside you.
"Having spent decades in the trenches of FDA compliance, I saw a clear need for consultants who don't just advise, but actively engage — rolling up their sleeves to build and implement solutions that genuinely work for medical device companies."
Senior-Level Expertise on Every Engagement
No Junior Staff, No Delegation
When you hire FDA RA Group, you work directly with senior consultants who have decades of hands-on experience. We don't delegate your project to junior staff or offshore teams.
Every audit, every 483 response, every quality system assessment is led by consultants who have been through FDA inspections, managed complex regulatory submissions, and built compliant operations from the ground up.
50+ Years Combined Experience
Our leadership team brings over 50 years of combined expertise in medical device and IVD regulatory affairs, quality assurance, and FDA compliance. This isn't theoretical knowledge — it's practical experience earned in manufacturing facilities, inspection rooms, and regulatory submission processes.
We've held director-level positions in regulatory affairs and quality assurance, managed multi-product portfolios, and led organizations through successful FDA inspections and submissions.
What Clients Say
"The team at FDA RA Group brought clarity to our quality system gaps and gave us a realistic roadmap to get inspection-ready. Their hands-on approach made all the difference — they didn't just audit us, they helped us fix the problems."
VP of Quality
Class II Medical Device Manufacturer
"We were facing our first FDA inspection with serious concerns about our CAPA process. FDA RA Group guided us through every step, prepared our team, and we came out with zero observations. I can't recommend them highly enough."
Regulatory Affairs Director
IVD Startup
"After receiving a 483, we needed experienced guidance fast. FDA RA Group delivered a comprehensive response strategy that FDA accepted without further action. Their expertise and responsiveness were exactly what we needed."
CEO
Medical Device Company
Client testimonials have been approved to share
What Guides Our Work
Practical First
Every recommendation we make has to work in practice — in your facility, with your team, on your timeline.
Risk-Based Thinking
We prioritize issues that carry the highest regulatory and business risk, so your resources are focused where they matter most.
Transparent Communication
We tell you what you need to hear, not what's easiest to say. Clear status, honest assessment, no surprises.