- Element has launched a first-of-its-kind, AI-powered regulatory intelligence platform to help medical device manufacturers bring products to market safely and more 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 approx.162 days, nearly twice the FDA goal of 90 days. RegNav will help to shorten this lead time.
- RegNav has been co-developed with a specialized team of leading regulatory experts, engineers, and data scientists.
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 more reliably for those in need.
RegNav’s proprietary software combines AI with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements, and testing needed to support the FDA submission process. Currently, bringing a medical device to market is a lengthy procedure with manufacturers facing a complex regulatory environment.
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 goal of 90 days. Delays in clearance are commonly caused by the need for multiple submission turnarounds when missing or additional information is required. In turn, manufacturers are experiencing vast losses of time and money.
To address these issues, RegNav has been co-developed with a specialized team of leading regulatory experts, engineers, and data scientists. The expert pool is comprised of ex-notified body regulatory professionals who have sought to ensure that the framework of RegNav is comprehensive and accurate.
Jo Wetz, CEO of Element, comments: “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 realize 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, shares: “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/approval under FDA CFR. Element is ambitious to expand RegNav to other jurisdictions, including EU Medical Device Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR). Find out more at regnav.com
Notes to Editors
Element RegNav is designed for companies both with and without existing regulatory support, offering two key services:
- RegNav Premium: Most suitable for companies with devices pre- or post-design freeze who are seeking to ensure that they are well-prepared ahead of submission. RegNav Premium provides a comprehensive and reliable compliance plan for a medical device in under two weeks. The compliance plan outlines the FDA pathway, regulations, FDA product codes, and standards that apply to a device and provides a summary of the testing requirements within each applicable standard.
- RegNav Verify: Most suitable for companies with an existing plan who want confidence that it is comprehensive before submission. RegNav Verify offers a double-checked & expert-backed review of the standards applicable to a medical device and identifies any gaps ahead of submission.
RegNav gives medical device manufacturers increased confidence that they’re testing the right thing using the right methodology.
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