Element is the solution to satisfy your compliance needs throughout the development cycle of your 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.

Our EMC laboratories in the US and UK hold a range of accreditations and approvals including BS EN 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 – specifically covering medical products.

EMC chambers at our facilities include a 10 meter chambers along with automated test methodologies to maximize testing efficiency.

Many medical device manufacturers are looking to add wireless features to their existing products. 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)
Expertise and Testing Services for Electronic Medical Devices
  • EMC Testing
  • Electromagnetic Safety Testing
  • Radio and Wireless Testing
  • Battery Testing
  • Environmental Testing
  • Microbiological Testing

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Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.

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