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Contract signedUnited Kingdom

Regulatory Compliance Services for Medical Devices

Awarded to SCARLET GLOBAL HOLDINGS LTD

NHS England(buyer)

Published
Published 19 June 2026
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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.

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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
Winner
  • SCARLET GLOBAL HOLDINGS LTD

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Notice history

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  1. Contract

    19 June 2026

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