About Element Hitchin - Safety Testing
Element Hitchin is our Safety Testing centre of excellence, with UKAS accreditation to BS EN ISO/IEC 17025:2005.
Element is a Notified Body for a number of the key European Directives (Low Voltage, Machinery, EMC, Radio and Telecommunication Terminal Equipment Directive and ATEX) as well as a National Certification Body and a Certification Body Test Laboratory under the IECEE’s CB Scheme and the Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components. Our expertise in Safety Testing and certification at Element Watford helps the whole supply chain import and export products to 167 countries throughout the world.
Our areas of technical expertise at Element Hitchin include Medical Testing & Regulatory Affairs, Safety Testing and Certifications & Approvals. We work with manufacturers of electrical medical devices and is approved to ISO 9001:2008 and typically provide medical regulatory testing and test reports to the European EN 60601 and American 510(k), which are the core standards for medical product verification.
Our technical experts help manufacturers of electronic medical devices with regulatory testing and global product approval services for manufacturers of Class I, II, and III electronic medical devices.