Contract signedUnited Kingdom
Regulatory Compliance Services for Medical Devices
- Published
- Published 19 June 2026
Overview
NHS England engaged SCARLET GLOBAL HOLDINGS LTD on 1 June 2026 for regulatory compliance services to obtain ISO 13485 Quality Management System certification through a two-stage external audit conducted by a UK Approved Body. The engagement was necessary to comply with upcoming UK medical device regulation changes in Spring 2026 that will reclassify certain software as a medical device (SaMD) products as higher-risk, requiring mandatory external certification to avoid regulatory non-compliance and operational restrictions.
Key details
- Country
- United Kingdom
- Status
- Contract signed
- Procedure
- Limited
- Published
- 19 June 2026
Award outcome
- Awarded value
- £75,000
- Award date
- 1 June 2026
- SCARLET GLOBAL HOLDINGS LTD
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Notice history
Every published notice in this contracting process, newest first.
Contract
19 June 2026
View notice ↗
Contracting authority
NHS England
BuyerLondon, United Kingdom
GB-PPON: PDPT-3135-BWWY
Authority website ↗
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