Element is the solution to satisfy your compliance needs throughout the development cycle of your Class I, II, and III electronic medical devices.Our medical regulatory affairs experts work with manufacturers of electrical medical devices to identify the appropriate testing standards for your medical products. This helps to remove both the cost and risk during the formal testing phase. Our EMC laboratories in the US and UK hold a range of accreditations and approvals including ISO/IEC 17025:2005 from NVLAP, A2LA or UKAS,approval to ISO 9001:2008, National Certification Body (NCB) and Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components, covering MED. EMC chambers at our facilities include 10 meter chambers along with automated test methodologies to maximize testing efficiency.Element is an established leader in wireless medical testing and approvals. MedRadio, Wireless Medical Telemetry, RFID, as well as Wi¬Fi ®, Bluetooth®, and GSMTM radio applications are all technologies that we see integrated into medical devices. Element is expert at obtaining the necessary wireless regulatory approvals for those applications.
MEDICAL REGULATORY TESTING STANDARDS
Element is capable of evaluating your medical device to demonstrate compliance within the EMC Directive and others, which include:
· EN/IEC 60601-1-2
· EN/IEC 60601-2-x
· US FDA 510(k)