Element's RegNav transforms medical device compliance
Element Materials Technology (Element), a global player in materials and product qualification testing, inspection, and certification services, recently unveiled the 18-month development journey of RegNav, its AI-driven regulatory intelligence platform for medical devices. This behind-the-scenes glimpse reveals Element's innovative approach to tackling significant industry challenges through cutting-edge technology.
The medical device industry faces substantial regulatory obstacles, with 75% of 510(k) applications being rejected on first submission, FDA Premarket Approval reviews averaging 180 days, and EU MDR certification taking up to 18 months. Element leveraged its extensive in-house expertise in medical device regulation, standards, and testing, including involvement in standard-drafting committees, to create RegNav.
RegNav addresses a critical need by bridging the gap between medical device developers and the intricate web of regulations, standards, and state-of-the-art requirements. It interprets these complexities based on a product’s intended purpose and technological characteristics, translating them into specific requirements and actionable insights. RegNav's goal is to streamline compliance and development planning, reducing the process from months to as little as two weeks.
Andrew Jordan, Chief Technology Officer of Element, explains: "Our 18-month head start with patent pending generative AI technology gives RegNav a significant edge, providing contextual regulatory insights that enable faster, more confident innovation in this complex landscape." James Pink, Director of Medical at Element, adds: "RegNav optimises compliance planning and accelerates time-to-market for medical devices while maintaining or enhancing product safety, ultimately making tomorrow safer than today."
The development of RegNav has catalysed broader digital transformation within Element. The company is pleased to announce the appointment of Natalie Seatter as Vice President of Digital. Natalie joins from OAG, a data platform for the global travel industry, and will lead Element’s digital strategy going forward.
Natalie Seatter, Vice President of Digital at Element, comments on her new role: "I'm excited to join Element at this pivotal time and look forward to building on RegNav’s foundation to drive further digital advancements across the organization."
Looking ahead, Element plans to expand RegNav's capabilities to cover EU Medical Device Regulation (MDR) and explore applications in connected devices and the built environment, further driving innovation in regulatory compliance.
