Element Materials Technology (Element) 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.
Element will perform electromagnetic compatibility (EMC) and wireless coexistence testing from five strategically positioned laboratories across the US. Element’s accreditation covers all medical products governed by FDA regulations.
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. Element 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.
Steve Hayes, Technical Director, Connected Technologies, Element
Element 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, Element’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.