Managing Testing Programmes

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TRaC can help design and manage your entire testing programme to support submissions to your chosen Notified Body for Medical Device Directive (MDD) approval.

We provide manufacturers with a complete managed service to support the complex nature of medical device testing, validation and certification. TRaC co-ordinates all your different testing partners, in-country testing requirements, local representatives and national bodies. This simplifies the process and allows you to collaborate with a single point of contact for all your testing, validation and certification needs, which in turn speeds up your time to market.

We can assist you with:

  • EMC Testing
  • Safety Testing
  • Radio and Wireless Testing
  • Battery Testing
  • Environmental Testing
  • Microbiological Testing

We can help in the assessment of product design, equipment specifications and quality systems to ISO 13485.

To learn more about how we can manage your entire medical device test programme, email your specification and requirements to contact.us@element.com, enter your details into the blue form or call us on the number in the top right corner of this page.