Element Materials Technology is the ideal choice for medical device testing manufacturers needing radio testing certification, qualification and regulatory approvals.
We work with manufacturers of electrical medical devices who wish to incorporate a wireless device into their product. Our medical regulatory affairs experts can identify the appropriate Radio Testing standards and certification, helping 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 are also a Notified Body for the Radio and Telecommunication Terminal Equipment (R&TTE) Directive, a Telecommunication Certification Body (TCB) and a Conformity Assessment Body (CAB) for Japan.Medical devices increasingly rely on radio technology to communicate; we can help by providing the following wireless radio testing and approvals services:
- North America
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