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TenderFTS · 06b95e

Regulatory Compliance Services for Medical Devices

NHS England
Status
complete
Estimated
—
Published
19 Jun 2026

Key facts

Notice ID
ocds-h6vhtk-06b95e
Awarded to
SCARLET GLOBAL HOLDINGS LTD
Source
Find a Tender

Timeline

  1. Published
    19 Jun 2026

Description

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 introduction of new or updated SaMDs and AIaMDs, and exposing NHS England to significant legal, reputational, and operational risks. This is not a discretionary activity—it is a statutory obligation

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Page 108 of 1605
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