London, UK - 9 October 2025 - Element Materials Technology (“Element”), a global leader in laboratory-based testing services, has become the first testing provider in the UK to be accredited under the U.S. Food and Drug Administration’s (FDA) Accreditation Scheme for Conformity Assessment (ASCA).
ASCA is a voluntary FDA initiative designed to improve the efficiency and predictability of the medical device premarket review process. Built on internationally accepted standards such as ISO/IEC 17025, the programme recognizes laboratories that demonstrate technical competence and robust quality systems. ASCA-accredited labs are also authorised to perform testing to selected FDA-recognised consensus standards, including IEC 60601 for medical electrical equipment.
For manufacturers, working with an ASCA-accredited testing provider like Element means greater consistency and predictability in FDA reviews. ASCA test reports are accepted more readily, helping to shorten submission timelines and accelerate market entry – delivering a competitive edge in the fast-paced medical device industry.
Element has long been a trusted ASCA-accredited provider in the United States, with multiple laboratories already participating in the program. The recent addition of UK facilities in Hull and Malvern to the ASCA programme extends Element’s global reach and reinforces its commitment to supporting medical device manufacturers with high-quality, regulatory-compliant testing services across both sides of the Atlantic.
“We’re extremely proud to be the first UK testing provider to achieve ASCA accreditation,” said Dr Fabian Schober, SVP, Connected Technologies & Mobility at Element. “This recognition not only validates the technical excellence of our UK teams but also provides our customers with a strategic advantage in navigating the FDA approval process more efficiently.”
In addition to ASCA-accredited EMC and safety testing, Element offers a comprehensive suite of services to medical device manufacturers including:
- IEC 60601 testing via its IEC Certification Body and Test Laboratory in both the UK and US
- NRTL (Nationally Recognized Test Laboratory) services
- Radio testing, regulatory advisory, global market access, and certification for medical devices
Customer enquiries regarding ASCA-accredited testing and other medical device services can be directed to the UK commercial team at commercial.team@element.com.
ENDS
About Element Materials Technology
Element is one of the world’s leading providers of laboratory-based testing services. We support 50,000+ customers operating in some of the world’s most technical and highly regulated industries where failure in use of their products, materials and technologies is not an option. Headquartered in London, UK, Element’s 8,500+ scientists, engineers, and technologists, work across a global network of 270+ laboratories, and support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable and achieve market access.
For more information about Element, please visit our website, connect with us on LinkedIn, X, Instagram and subscribe to our YouTube channel.
About Element’s Connected Technologies & Mobility Business Unit
Element Connected Technologies & Mobility, a business unit of Element Materials Technology, provides testing, inspection, and certification services for connected devices and mobility solutions. With over 40 specialized laboratories around the world, and designation as an officially recognized Bluetooth Qualification Test Facility (BQTF) in the US, we help manufacturers launch products that meet global standards for connectivity, safety, and performance. Our 1,000+ experts support a wide range of technologies, including consumer electronics, IoT, autonomous vehicles, and medical devices. By combining deep domain knowledge with Element’s global capabilities, we accelerate time-to-market and ensure compliance across increasingly complex regulatory landscapes.
For more information, visit: element.com/connected-technologies.
Media Contact: Kate Aldridge, VP Communications, E: kate.aldridge@element.com M:+44 7767 705364