Documentation Review and Assessment

Medical Device
TRaC can provide manufacturers of medical products with confidence when submitting documentation to their chosen Notified Body.

We can assist you by independently auditing your product’s design, equipment specifications and quality management systems against the requirement for regulatory compliance for the product’s intended market prior to submission.

We can help with the final preparation of your:

  • Technical file
  • Risk management file
  • Usability file
  • Software verification file
  • Quality Management System processes and standard operating procedures - ISO13485

By conducting this independent audit on your behalf we can limit your cost and risk of a prolonged submission process by identifying any gaps in compliance in advance, which would have otherwise delayed the final product validation, preventing a product going to market.

We can assess any existing quality management system documentation for compliance with ISO13485 and the following regulations:

  • Food and Drugs Association (FDA)
  • Quality System Regulation (QSR)
  • Medical Device Directive (MDD)
  • Canadian Medical Device Conformity Assessment System (CMDCAS)

To learn more about how we can assist in reviewing your documentation prior to submission, email your 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.