Element Unveils RegNav: AI-Powered Platform for Safer Medical Device Development

Monday, June 17, 2024

Element Materials Technology (Element) has introduced Element RegNav (RegNav), a new AI-powered platform designed to navigate regulatory intelligence specifically for the medical device industry. This platform aims to help medical device manufacturers efficiently bring their innovations to market while ensuring compliance with FDA regulatory pathways.

RegNav utilizes proprietary AI software along with expert guidance from regulatory professionals to assist manufacturers in identifying the necessary regulations, standards, requirements, and testing procedures required for FDA submissions. This initiative seeks to streamline the often complex and time-consuming process of gaining FDA clearance for medical devices.

Currently, the average time for FDA 510(k) premarket submission clearance significantly exceeds the FDA's target of 90 days, often due to multiple submission turnarounds caused by missing or incomplete information. RegNav aims to reduce these delays by providing a clear and comprehensive framework for regulatory compliance.

Developed in collaboration with regulatory experts, engineers, and data scientists, RegNav incorporates insights from former notified body regulatory professionals to ensure accuracy and completeness in its regulatory framework.

CEO of Element, emphasizes that RegNav's primary goal is to facilitate the safe and efficient market entry of life-enhancing medical devices, addressing the challenges faced by manufacturers in navigating regulatory requirements.

The synergistic relationship between RegNav and Element's existing services, noting that once a regulatory pathway is identified, Element can further support customers through the testing and certification process, serving as a comprehensive partner in achieving market access.

RegNav currently supports FDA CFR requirements for Class I, II, and III medical devices, with future plans to expand its capabilities to include EU Medical Device Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR).

For companies both with and without existing regulatory support, RegNav offers two key services:

  • RegNav Premium: Provides a detailed compliance plan within under two weeks, outlining FDA pathways, applicable regulations, FDA product codes, standards, and testing requirements.
  • RegNav Verify: Offers a thorough review of existing compliance plans to ensure comprehensive preparation before submission, identifying any potential gaps.

Element aims to empower medical device manufacturers with confidence in their regulatory strategies, ensuring they conduct appropriate testing using the correct methodologies to meet regulatory standards effectively.






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