Why Regulatory Assist?
We bridge the gap between complex regulations and practical business needs.
Meet the Founder
Anil Sharma Kandel founded Regulatory Assist with a simple mission: to make medical device compliance less painful and more predictable.
With over 20 years of hands-on experience in the medical device industry, Anil has led teams through successful FDA 510(k) clearances, ISO 13485 certifications, and EU MDR transitions. He believes that a good regulatory strategy is a competitive advantage, not just a checkbox.
Based in Albuquerque, NM, Regulatory Assist serves clients globally, bringing a pragmatic, "audit-ready" mindset to every project.
Our Core Values
We operate with transparency, speed, and precision.
Speed to Market
We understand that every day counts. We work efficiently to get your device approved faster.
Audit Readiness
We don't just write documents; we build evidence that stands up to the toughest auditors.
Client Partnership
We act as an extension of your team, providing mentorship and knowledge transfer along the way.