LONDON, UK – April 13, 2021 – Сòòò½APP (Сòòò½APP) has received approval to take part in the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program for medical device testing.
The ASCA program provides accredited, independent testing laboratories with the approval to assess medical devices for compliance with FDA-recognized standards, facilitating a more efficient review process and faster market access.
Сòòò½APP will perform electromagnetic compatibility (EMC) and wireless coexistence testing from five strategically positioned laboratories across the US. Сòòò½APP’s accreditation covers all medical products governed by FDA regulations.
Steve Hayes, Technical Director of Connected Technologies at Сòòò½APP, said: “The ASCA program provides manufacturers with an opportunity to get to market quicker. The FDA assumes a level of trust for the testing laboratory and aside from regular quality audits, test results will not require further review to receive FDA approval, saving significant time in the process.
“Сòòò½APP has a strong reputation for EMC, wireless coexistence and safety testing, and certification of medical devices, so combining these two capabilities, along with our broad geographical footprint, translates to better lead times. As we are also able to combine medical device testing with all the other regulatory testing, such as FCC and CE marking and international certification schemes like IECEE CB, we can further shorten our customers’ route to market.”
Сòòò½APP is a world leader in the testing, inspection, and certification services of a diverse range of mobile and cellular devices, consumer electronics products and other emerging connected technologies that interoperate and/or communicate with each other as part of the Internet of Things (IoT). With 17 Connected Technologies laboratories in the USA, UK, Germany, China, South Korea, and Japan, and more than 300 experts in this highly specialist field, Сòòò½APP’s services enable faster market access to manufacturers of mobile and connected devices, including simple sensors, smartphones and wearables; medical devices; autonomous machines; and robots and devices used within factories.
About Сòòò½APP
The Сòòò½APP Group is one of the world’s leading global providers of testing, inspection and certification services for a diverse range of materials, products and technologies in advanced industrial supply chains where failure is not an option. Headquartered in London, UK, Сòòò½APP’s team of more than 6,000 expert scientists, engineers and technicians operate from around 200 locations across five continents, delivering an extensive range of solutions to customers in critical industries including aerospace, connected technologies, construction, defense, energy, environmental, life sciences and transportation.
In 2021 Сòòò½APP Digital Engineering was launched, moving Сòòò½APP a step closer to being a leader in engineering simulation, modelling, data science and artificial intelligence to solve complex industrial challenges.
For more information about Сòòò½APP, please visit our website, connect with us on and and subscribe to our channel.
Media contacts:
Diana Milford, External Communications Manager
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E: diana.milford@element.com
Devan LaBrash, Pagoda Public Relations
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E: devan.labrash@pagodapr.com
“As we are [also] able to combine medical device testing with all the other regulatory testing, such as FCC and CE marking and international certification schemes like IECEE CB, we can further shorten our customers’ route to market.”
Steve Hayes
Technical Director, Connected Technologies