Element Materials Technology has launched RegNav, an AI-powered regulatory intelligence platform designed to facilitate safer and more efficient medical device development.
The RegNav platform aims to simplify the US FDA regulatory pathways for medical device manufacturers, enabling medical innovations to reach the market with enhanced safety and reliability.
Go deeper with GlobalData
Its software integrates AI with expert insights, assisting medical device manufacturers in navigating the complex landscape of regulations, standards and testing requirements necessary for FDA submissions.
Currently, the platform caters to Class I, II and III medical devices seeking clearance or approval under FDA Code of Federal Regulations.
Element has set its sights on broadening RegNav’s capabilities to encompass other regulatory domains, including the EU’s Medical Device Reporting and In Vitro Diagnostic Regulation.
Element CEO Jo Wetz said: “The end goal for RegNav is simple: to help our customers bring life-enhancing devices to market safely and more efficiently.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataElement chief commercial officer Renae Leary said: “There is an incredible synergy between our new RegNav offering and existing services.
“Once we identify a regulatory pathway, we can also support customers in the testing and certification process, acting as a true partner for market access. RegNav strips away the complexity to give customers a clear path to compliance.”
Element RegNav is tailored to support companies both with and without established regulatory frameworks, offering two principal services: RegNav Premium and RegNav Verify.
RegNav Premium is ideal for companies at the pre or post-design freeze stages, ensuring readiness for submission, while RegNav Verify is suited for companies with an existing compliance plan seeking assurance of its comprehensiveness prior to submission.
