Element Materials Technology (Element), a global provider of testing, inspection, and certification (TIC) services, has introduced Element RegNav (RegNav), its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially launched to support FDA regulatory pathways, RegNav aims to facilitate the safe and reliable market introduction of medical innovations for those in need.
This news follows on from Element’s ribbon cutting ceremony on its new testing facility in Surrey Hills, which it has invested $10 million in.
RegNav’s proprietary software integrates AI with expert guidance to assist medical device manufacturers in identifying the regulations, standards, requirements, and testing necessary for the FDA submission process. Currently, bringing a medical device to market is a lengthy and complex procedure for manufacturers.
According to insights from BTIG, a global financial services firm, the average 510(k) premarket submission clearance takes approximately 162 days, nearly twice the FDA’s target of 90 days. Delays are often due to the need for multiple submission rounds when additional information is required, resulting in significant time and financial losses for manufacturers.
To address these challenges, RegNav has been co-developed with a specialised team of regulatory experts, engineers, and data scientists. This team includes former notified body regulatory professionals who have ensured the RegNav framework is comprehensive and accurate.
Jo Wetz, CEO of Element, said: “The end goal for RegNav is simple, to help our customers bring life-enhancing devices to market safely and more efficiently. Speaking to our existing medical device customers we realise there is a real opportunity to alleviate confusion around medical device regulation and standards, and further enhance our role as a trusted partner in their compliance and certification journey.”
Renae Leary, Chief Commercial Officer at Element, added: “There is an incredible synergy between our new RegNav offering and existing services. Once we identify a regulatory pathway, we can also support customers in the testing and certification process, acting as a true partner for market access. RegNav strips away the complexity to give customers a clear path to compliance.”
RegNav currently supports Class I, II, and III medical devices seeking clearance or approval under FDA CFR. Element is keen to expand RegNav to other jurisdictions, including EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
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