Element Announces RegNav, its First AI-Powered Platform Promoting Safer and More Reliable Medical Device Development
June 17 2024 - 6:01AM
Business Wire
- Element has launched a first-of-its-kind, AI-powered regulatory
intelligence platform to help medical device manufacturers bring
products to market safely and more 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 approx.162 days, nearly
twice the FDA goal of 90 days. RegNav will help to shorten this
lead time.
- RegNav has been co-developed with a specialized team of leading
regulatory experts, engineers, and data scientists.
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)-powered regulatory intelligence
platform for medical devices. Initially launched to support FDA
regulatory pathways, RegNav will help bring medical innovations to
market safely and more reliably for those in need.
RegNav’s proprietary software combines AI with expert guidance
to support medical device manufacturers in identifying the
regulations, standards, requirements, and testing needed to support
the FDA submission process. Currently, bringing a medical device to
market is a lengthy procedure with manufacturers facing a complex
regulatory environment.
According to insights from BTIG, a global financial services
firm, the average 510(k) premarket submission clearance takes
approximately 162 days, nearly twice the FDA goal of 90 days.
Delays in clearance are commonly caused by the need for multiple
submission turnarounds when missing or additional information is
required. In turn, manufacturers are experiencing vast losses of
time and money.
To address these issues, RegNav has been co-developed with a
specialized team of leading regulatory experts, engineers, and data
scientists. The expert pool is comprised of ex-notified body
regulatory professionals who have sought to ensure that the
framework of RegNav is comprehensive and accurate.
Jo Wetz, CEO of Element, comments: “The end goal for
RegNav is simple: to help our customers bring life-enhancing
devices to market safely and more efficiently. Speaking to our
existing medical device customers we realize there is a real
opportunity to alleviate confusion around medical device regulation
and standards, and further enhance our role as a trusted partner in
their compliance and certification journey.”
Renae Leary, Chief Commercial Officer at Element, shares:
“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.”
RegNav currently supports Class I, II, and III medical devices
seeking clearance/approval under FDA CFR. Element is ambitious to
expand RegNav to other jurisdictions, including EU Medical Device
Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR). Find out
more at regnav.com
Notes to Editors
Element RegNav is designed for companies both with and without
existing regulatory support, offering two key services:
- RegNav Premium: Most suitable for companies with devices
pre- or post-design freeze who are seeking to ensure that they are
well-prepared ahead of submission. RegNav Premium provides a
comprehensive and reliable compliance plan for a medical device in
under two weeks. The compliance plan outlines the FDA pathway,
regulations, FDA product codes, and standards that apply to a
device and provides a summary of the testing requirements within
each applicable standard.
- RegNav Verify: Most suitable for companies with an
existing plan who want confidence that it is comprehensive before
submission. RegNav Verify offers a double-checked &
expert-backed review of the standards applicable to a medical
device and identifies any gaps ahead of submission.
RegNav gives medical device manufacturers increased confidence
that they’re testing the right thing using the right
methodology.
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, work across a
global network of over 270+ laboratories, support customers from
early R&D, through complex regulatory approvals, and into
production ensuring their products are safe and sustainable and
achieve market access.
In 2021, Element set out its new, industry-leading environmental
commitments, adopting science-based targets and committing to net
zero emissions across its 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 Twitter, and subscribe
to our YouTube channel.
About Element RegNav
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
compliance and accelerates your path towards market. It combines
expert insights with AI, giving you a comprehensive picture of your
safety and performance requirements. Save time, reduce stress, and
focus on bringing your innovation to market.
For more information about RegNav, please visit our website, or
connect with us on LinkedIn.
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Element Materials Technology Cheyenne O’Kane 07748 281597
Cheyenne.okane@element.com