Element is the the perfect partner for medical regulatory testing and global product approval services for manufacturers of Class I, II, and III electronic medical devices.
We work with manufacturers of electrical medical devices from the conception of their products with our medical regulatory affairs experts, who identify the appropriate testing standards for your medical products. This helps to remove both the cost and risk from medical product verification and validation during the formal testing phase.
Element is UKAS accredited to BS EN ISO/IEC 17025:2005 and approved to ISO 9001:2008; we are a National Certification Body (NCB) and a Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components.
We 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.
We provide expertise and testing services for medical devices, including:
- EMC Testing
- Safety Testing
- Radio and Wireless Testing
- Battery Testing
- Environmental Testing
- Microbiological Testing