Element RegNav

Element RegNav

Medical Equipment Manufacturing

The future of medical device compliance: intelligent, automated, reliable.

About us

Digital compliance conceived, developed, and backed by industry experts. We are reimagining how medical device companies engage with regulation, helping support and accelerate life-enhancing tools to patients. Leveraging over 200-years of testing experience, combined with patent-pending AI technology, RegNav provides a complete picture of safety and performance requirements, to support our customers in bringing medical devices to market sooner.

Website
www.RegNav.com
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Specialties
software, standards, regulatory compliance, FDA 510(k), medical devices, FDA 21 CFR, artificial intelligence, EU MDR & IVDR, CE marking, in vitro diagnostics, regulatory affairs, and UKCA

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