Matthew BoyleElement Materials Technology (Element) has launched Element RegNav (RegNav), an innovative regulatory intelligence platform tailored for medical device manufacturers. This AI-powered solution simplifies the complex landscape of FDA regulations, streamlining the path to market for life-enhancing medical innovations.
RegNav integrates advanced AI algorithms with expert guidance to navigate the intricate requirements, standards, and testing protocols necessary for FDA submissions. This initiative addresses significant challenges in the regulatory process, aiming to reduce clearance times and enhance compliance efficiency.
The platform, initially designed to support FDA pathways, is poised to extend its capabilities to encompass global standards such as EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Element’s $10 million investment in a new testing facility underscores its commitment to advancing regulatory compliance and fostering innovation in medical device technology.
Element CEO Jo Wetz emphasizes RegNav’s pivotal role in accelerating market access for manufacturers, ensuring adherence to stringent regulatory frameworks while minimizing delays and operational costs. Renae Leary, Chief Commercial Officer, highlights RegNav’s synergy with existing services, offering comprehensive support from regulatory strategy formulation to certification.
As Element continues to pioneer in regulatory intelligence with RegNav, the platform stands poised to redefine standards in medical device compliance, empowering manufacturers to navigate regulatory landscapes with confidence and efficiency.
Element Launches RegNav: AI-Powered FDA Regulatory Intelligence Platform
Element Materials Technology ( Element ), a global provider of testing, inspection, and certification ( TIC ) services, has introduced Element RegNav ( RegNav ), its first artificial intelligence ( AI )- powered regulatory intelligence platform for medical devices. RegNav was originally created to support FDA regulation pathways, but now it aims to make it easier for people in need to get medical innovations for a safe and dependable market.
This announcement follows Element’s ribbon-cutting ceremony for its fresh,$ 10 million testing facility in Surrey Hills.
RegNav’s custom software integrates AI with expert guidance to assist medical device manufacturers in identifying the regulations, standards, requirements, and testing needed for the FDA submission process. Now, bringing a medical device to market is a lengthy and complicated 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 frequently caused by the need for multiple submission rounds when extra information is needed, which causes manufacturers to lose time and money.
To address these challenges, RegNav has been co-developed with a professional team of governmental experts, engineers, and data scientists. Previous notified body regulatory professionals who have worked to make sure the RegNav framework is thorough and accurate are included in this team.
Element Unveils RegNav for Simplified FDA Medical Device Compliance
Jo Wetz, CEO of Element, said:” The end goal for RegNav is simple, to help our customers bring life- enhancing devices to market properly and more quickly. When speaking with our current medical device customers, we understand that there is a real chance to help ease the confusion surrounding clinical device regulations and standards and strengthen our position as a reliable partner in their compliance and certification journey.
Renae Leary, Chief Commercial Officer at Element, added:” There is an amazing synergy between our fresh RegNav offering and existing services. As a true partner for market access, we can also assist clients in the testing and certification process when we have identified a regulatory pathway. RegNav eliminates complexity to provide customers with a clear path to compliance.
RegNav now supports Class I, II, and III health devices that have been approved or cleared by FDA CFR. RegNav is eager to be expanded to other states, including the EU Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation ( IVDR).
