LONDON, UK – July 17, 2024 – Element Materials Technology (Element), a global leader in materials and product qualification testing, inspection, and certification services (TIC), today shared insights into the 18-month development journey of RegNav, its AI-powered regulatory intelligence platform for medical devices. This behind-the-scenes look highlights the innovative approach Element took to address critical industry challenges through advanced technology.
The medical device industry faces significant regulatory hurdles, with 75% of 510(k) applications rejected on first submission, FDA Premarket Approval reviews averaging 180 days, and EU MDR certification taking up to 18 months [1]. Element's unique position, with in house expertise in medical device regulation, standards and testing, including standard-drafting committees, provided the foundation for RegNav's development.
RegNav fills a crucial gap between medical device developers and the complex regulations, standards and state of the art requirements surrounding their products. It navigates these complexities based on a product’s intended purpose and technological characteristics, translating them into -specific requirements and insights. RegNav aims to reduce compliance and development planning time 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 optimizes 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 catalyzed 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, the leading 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.
For more information about RegNav's technical capabilities, visit regnav.com.
References: [1] Greenlight Guru. Common mistakes that can tank your FDA 510(k). 16 Nov 2017. FDA Post Market Approval (PMA) Review Process 13 Sep 2021. European Commission Notified bodies survey on certifications and applications 13 Mar 2024.
About Element Materials Technology
The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.9,000 scientists, engineers, and technologists, working in 270+ laboratories around the world, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable.
In 2021, Element set out its new, industry-leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection, and certification industry from Sustainalytics, a global leader in ESG research and data.
For more information about Element, please visit our website, connect with us on LinkedIn, Instagram, and X, and subscribe to our YouTube channel.