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Posted on by darion

NEWS RELEASE: Element Announces RegNav, First AI-Powered Platform Promoting Safer, More Reliable Medical Device Development

  • Element has launched a first-of-its-kind AI-powered regulatory intelligence platform designed to help medical device manufacturers bring products to market safely and reliably.
  • RegNav supports FDA Classes I, II and III, as well as 510(K) and De Novo/PMA pathways.
  • The average 510(k) clearance takes about 162 days, which is almost double the FDA’s goal of 90 days. RegNav will help reduce this turnaround time.
  • RegNav was developed together with a dedicated team of leading regulatory experts, engineers and data analysts.

LONDON – Element Materials Technology (Element), a leading global provider of testing, inspection and certification (TIC) services, today announced the launch of Element RegNav (RegNav), its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially launched to support FDA regulatory pathways, RegNav will help bring medical innovations to market safely and reliably for those in need.

RegNav’s proprietary software combines artificial intelligence with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements and testing necessary to support the FDA application process. Currently, introducing a medical device to the market is a long-term procedure in which manufacturers must deal with a complex regulatory environment.

According to insights from BTIG, a global financial services company, the average premarket processing time for a 510(k) application takes approximately 162 days, which is almost twice as long as the FDA’s goal of 90 days. Delays in settlement are often caused by the need to submit applications multiple times when information is missing or additional information is needed. In turn, producers experience huge losses of time and money.

To solve these problems, RegNav was developed together with a dedicated team of leading regulatory experts, engineers and data analysts. The expert pool consists of former notified body regulatory specialists who have strived to ensure the comprehensiveness and accuracy of the RegNav framework.

Jo Wetz, CEO of Element, comments: “RegNav’s ultimate goal is simple: to help our customers bring life-enhancing devices to market safely and more efficiently. As we speak to our existing medical device customers, we recognize that there is a real opportunity to dispel confusion around medical device regulations and standards and further strengthen our role as a trusted partner in their compliance and certification journey.

Renae Leary, Chief Commercial Officer at Element, says: “There is incredible synergy between our new RegNav offering and our existing services. Once a regulatory pathway has been identified, we can also 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 currently supports Class I, II and III medical devices seeking clearance/approval under the FDA CFR. Element has ambitious plans to expand RegNav to other jurisdictions, including the EU Medical Device Reporting (MDR) and the In Vitro Diagnostics Regulation (IVDR). More information can be found at regnav.com

The opinions expressed in this press release are solely those of the author and do not necessarily reflect the opinions of Medical Design & Outsourcing or its employees.