Worldwide medical electrical equipment and in vitro diagnostic medical devices are controlled by strictly regulated national and international approval procedures which include testing, certification and audit requirements.
Both current and upcoming regulations place a focus on evaluating and reducing the risks involved with medical devices and their connections to other devices and/or IT networks.
Eurofins Medical Device Testing laboratories and certification services can help you ensure compliance with the latest standards and regulations, while achieving Global Market Access (GMA) in a cost and time efficient manner.
*Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case-by-case basis.
Testing Services for Medical Electrical Equipment | ||
Safety & Performance Testing | ||