Element Materials Technology has recently introduced RegNav, an innovative AI-driven platform focused on delivering regulatory intelligence for medical devices. The objective of this groundbreaking platform is to simplify the process of bringing life-enhancing medical innovations to the market, while ensuring utmost safety and efficiency.
The creation of RegNav is a direct response to the complex regulatory pathways that medical device manufacturers encounter, particularly in the United States. By harnessing the power of AI and expert guidance, the platform offers manufacturers the necessary support to comprehend regulations, standards, requirements, and testing essential for FDA submission.
Industry insights from BTIG reveal that the average premarket submission clearance for medical devices surpasses the FDA’s 90-day goal, resulting in substantial delays and financial setbacks for manufacturers. RegNav seeks to combat these challenges by furnishing a comprehensive compliance plan within a timeframe of fewer than two weeks, as well as expert-backed reviews for existing regulatory plans.
RegNav provides two primary services: RegNav Premium, which yields a comprehensive compliance plan for companies preparing for submission, and RegNav Verify, which offers a meticulous review of existing plans to ensure thoroughness. This strategy aims to simplify the intricate regulatory landscape, offering companies a clear pathway to compliance.
Renae Leary, Chief Commercial Officer of Element, underlines the synergistic relationship between RegNav and the company’s existing services, highlighting the assistance provided for testing and certification processes. Presently, the platform backs medical devices seeking clearance or approval under FDA CFR, with future plans to encompass other jurisdictions such as EU Medical Device Reporting and In Vitro Diagnostic Regulation.
As a global leader in testing, inspection, and certification services, Element Materials Technology is dedicated to assisting customers across diverse industrial supply chains. With a team comprising over 9,000 scientists, engineers, and technologists, the company is committed to guaranteeing the safety, sustainability, and market access of products.
In conclusion, the introduction of RegNav by Element marks a significant advancement in the realm of medical device regulation, offering a technology-driven solution to streamline the process of introducing innovative medical devices to the market. The integration of AI and expert guidance within the platform holds the potential to alleviate challenges faced by manufacturers, ultimately benefiting those in need of life-enhancing medical solutions.
Sources:
– Element Materials Technology
– BTIG