Element announces RegNav, its first AI-powered platform promoting safer and more reliable medical device development

• Element has launched a first-of-its-kind AI-powered regulatory intelligence platform designed to help medical device manufacturers bring products to market safely and 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 about 162 days, which is almost double the FDA’s goal of 90 days. RegNav will help reduce this turnaround time.

• RegNav was developed together with a dedicated team of leading regulatory experts, engineers and data analysts.

LONDON–(BUSINESS WIRE)–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) intelligence platform solution regulatory framework for medical devices. Initially launched to support FDA regulatory pathways, RegNav will help bring medical innovations to market safely and reliably for those in need.

RegNav’s proprietary software combines artificial intelligence with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements and testing necessary to support the FDA application process. Currently, introducing a medical device to the market is a long-term procedure in which manufacturers must deal with a complex regulatory environment.

According to insights from BTIG, a global financial services company, the average premarket processing time for a 510(k) application takes approximately 162 days, which is almost twice as long as the FDA’s goal of 90 days. Delays in settlement are often caused by the need to submit applications multiple times when information is missing or additional information is needed. In turn, producers experience huge losses of time and money.

To solve these problems, RegNav was developed together with a dedicated team of leading regulatory experts, engineers and data analysts. The expert pool consists of former notified body regulatory specialists who have strived to ensure the comprehensiveness and accuracy of the RegNav framework.

Jo Wetz, CEO of Element, comments: “RegNav’s ultimate goal is simple: to help our customers bring life-enhancing devices to market safely and more efficiently. As we speak to our existing medical device customers, we recognize that there is a real opportunity to dispel confusion around medical device regulations and standards and further strengthen our role as a trusted partner in their compliance and certification journey.

Renae Leary, Chief Commercial Officer at Element, shares: “There is incredible synergy between our new RegNav offering and existing services. Once a regulatory pathway has been identified, we can also support customers through the testing and certification process, acting as a true market access partner. RegNav eliminates complexity and provides customers with a clear path to compliance.

RegNav currently supports Class I, II and III medical devices seeking clearance/approval under the FDA CFR. Element has ambitious plans to expand RegNav to other jurisdictions, including the EU Medical Device Reporting (MDR) and the In Vitro Diagnostics Regulation (IVDR). More information can be found at regnav.com

Notes for editors

Element RegNav is designed for businesses both with and without existing regulatory support, offering two key services:

• RegNav Premium: Most suitable for companies whose equipment has been frozen before or after design and who want to ensure they are well prepared before submitting an application. RegNav Premium provides a comprehensive and reliable medical device compliance plan in less than two weeks. The compliance plan identifies the FDA pathway, regulations, FDA product codes, and standards applicable to the device and provides a summary of the testing requirements under each applicable standard.
• RegNav Check: Most suitable for companies with an existing plan who want to ensure it is comprehensive before submitting. RegNav Verify offers a double-checked and expert-backed overview of the standards applicable to a medical device and identifies any gaps before submitting an application.

RegNav gives medical device manufacturers more confidence that they are testing the right thing using the right methodology.

About the technology of elemental materials

Element Materials Technology Group is one of the world’s leading 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 approximately 9,000 scientists, engineers and technologists work across a global network of over 270 laboratories, supporting customers from early R&D, through complex regulatory approvals, through to manufacturing, ensuring their products are safe and sustainable and gain market access.

In 2021, Element unveiled its new industry-leading environmental commitments, adopting science-based targets and committing to achieve net zero emissions across its global operations by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in testing , inspections, and certifications from Sustainalytics, a global leader in ESG research and data.

For more information about Element, visit our website, connect with us on LinkedIn, Instagram and Twitterand subscribe to our YouTube channel.

Information about the RegNav element

Element RegNav is the future of medical device compliance: intelligent, automated and reliable. Leveraging Element’s global expertise and trusted reputation, the platform guides you through the compliance process and accelerates your path to market. It combines expert knowledge with artificial intelligence to provide a comprehensive view of security and performance requirements. Save time, reduce stress and focus on bringing your innovation to market.

For more information about RegNav, visit our website or connect with us on LinkedIn.

Communication

Elemental materials technology

Cheyenne O’Kane

07748 281597

[email protected]