Who We Are…
Regulatory Compliance Consultants was founded on firsthand experience in the medical device industry—built by quality and regulatory leaders who have supported some of the world’s most recognized device manufacturers. With decades of experience navigating ISO 13485, MDSAP, FDA, and EU MDR/IVDR requirements, we understand both sides of the regulatory equation—what regulatory authorities look for, and what manufacturers need to succeed.
We bring more than theory—we bring practical, real-world insight gained from working with start-ups, global organizations, and everything in between. Our approach is hands-on, collaborative, and deeply strategic. We don’t just help you meet requirements—we help you build systems and strategies that reduce risk, enable growth, and give you a competitive edge in a constantly changing regulatory environment.
At our core, we’re committed to helping you transform compliance from a checkbox exercise into a true business advantage.
Contact us
Ready to reduce regulatory risk and turn compliance into your competitive advantage? Whether you need expert guidance on QMS implementation, regulatory strategy, audit readiness, or remediation, we're here to help.
Reach out today to schedule a free 30 minute consultation or learn more about how we can support your goals in the evolving medical device landscape.
Let’s connect—your compliance journey starts here.
raymond.yan@meddevrcc.com
(949) 300-4755