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Technical Assurance

 

SMTL carries out technical assurance of documentation for NWSSP Procurement Services and on a commercial basis for healthcare organisations and industry.

What documents does SMTL assess?

  • Regulatory documentation:
    • Declaration of conformity MDD/MDR/UKCA or PPE Regulation
    • Module B certification – from a Notified/Approved Body e.g. BSI
    • Module C2/D certification from a Notified/Approved Body e.g. BSI
  • Proof of adhering to a quality management system
    • ISO 13485 certificates
    • ISO 9001 certificates
  • Technical documentation
    • Test reports – e.g. EN 455, EN 14683, etc.
    • Biocompatibility reports

If you have a potential project you wish to discuss or have any questions, please contact smtl.info@wales.nhs.uk.