Element Materials Technology has been on an 18-month journey to develop RegNav, its AI-powered regulatory intelligence platform for medical devices. 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.

The medical device industry faces significant regulatory hurdles. 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 combines expert insights with AI, giving a detailed picture of a medical device’s safety and performance requirements.

Andrew Jordan, Chief Technology Officer of Element, explained: "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, said: "RegNav optimizes compliance planning and accelerates time-to-market for medical devices while maintaining or enhancing product safety, ultimately making tomorrow safer than today."

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.

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