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Eurofins E&E Is Now An FDA ASCA-Accredited Laboratory For Medical Device Testing

On April 12th, 2021, Eurofins E&E North America, an accredited ISO/IEC 17025 test laboratory, achieved ASCA recognition by the U.S. Food and Drug Administration (FDA), for Premarket Testing of Medical Devices. Launched on September 25th, 2020, the voluntary  Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program was devised to enhance consistency and predictability in the... Read More

Eurofins’ Finland’s Notified Body Achieves Designation Under the New Medical Devices Regulation (EU) 2017/745

On April 7th, 2021, Eurofins Expert Services Oy (No. 0537) became a Notified Body designated under the new Medical Devices Regulation (MDR). Eurofins can now offer, to medical device manufacturers worldwide, certification services according to Regulation (EU) 2017/745 for European market access covering an extensive range of medical device technologies1. The new Medical Device Regulation... Read More

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Eurofins E&E North America Awarded Status of Authorized Test Laboratory (ATL) for the CTIA Cybersecurity Certification Program

Eurofins E&E North America Awarded Status of Authorized Test Laboratory (ATL) for the CTIA Cybersecurity Certification Program Santa Clara Testing Facility Now an Authorized Test Laboratory for CTIA Cybersecurity Certification Program Eurofins Electrical and Electronics (E&E) North America- part of the Eurofins global network of premier testing, inspection, and certification laboratories, has been awarded the... Read More