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Element introduces a regulatory intelligence platform for medical devices

Posted on by darion

RegNav’s proprietary software integrates artificial intelligence with expert knowledge. Source: THICHA SATAPITANON/Shutterstock.

Element Materials Technology has launched RegNav, an AI-powered regulatory intelligence platform designed to facilitate safer and more efficient medical device development.

The RegNav platform aims to simplify the U.S. Food and Drug Administration (FDA) regulatory pathways for medical device manufacturers, enabling medical innovations to be brought to market with greater safety and reliability.

Its software integrates artificial intelligence with expert knowledge to help medical device manufacturers navigate the complex landscape of regulations, standards and testing requirements necessary to submit applications to the FDA.

The platform currently supports Class I, II and III medical devices seeking authorization or approval under the FDA Code of Federal Regulations.

Element aimed to expand RegNav’s capabilities to cover other regulatory areas, including EU medical device reporting regulations and the in vitro diagnostics regulation.

Element CEO Jo Wetz said: “RegNav’s ultimate goal is simple: to help our customers bring life-enhancing devices to market safely and more efficiently.”

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Element commercial director Renae Leary said: “There is incredible synergy between our new RegNav offering and existing services.

“Once a regulatory pathway is identified, we will also be able to support customers through the testing and certification process, acting as a true market access partner. RegNav eliminates complexity and provides customers with a clear path to compliance.

RegNav Element is tailored to support businesses both with and without an established regulatory framework, offering two main services: RegNav Premium and RegNav Verify.

RegNav Premium is ideal for companies in the pre- or post-design freeze stage, ensuring they are ready for submission, while RegNav Verify is suitable for companies with an existing compliance plan who want to ensure it is comprehensive before submission.