- Type
- award, contract
- Procedure
- Below threshold - limited competition
- Ref. number
- 058183-2026
The procurement covers regulatory compliance services for medical devices, specifically the engagement of a UK Approved Body to conduct a two-stage external audits (Stage 1 and Stage 2) in line with agreed timelines, to …
urgently achieve ISO 13485 Quality Management System certification. The deliverables will ensure that our medical devices are safe, effective, reliable and meet internationally recognized standard.
With the UK medical device regulations set to change in Spring 2026, several currently self-certified,
low-risk SaMDs will be reclassified as higher-risk devices. This means external certification by a UK Approved Body (e.g., BSI) will become mandatory. Failure to achieve this will result in an “innovation freeze,” preventing the introducti