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.