Regulatory Compliance Services for Medical Devices
This is a contract result notice, not an open opportunity. Details from the official award data.
The procurement contact named on the official notice.
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
What the supplier must deliver
The deliverables will ensure that our medical
The deliverables will ensure that our medical devices are safe, effective, reliable and meet internationally recognized standard.
Derived from the notice text — always confirm against the original documents.
What this notice demands of you
1 named, none in explicit obligation language. Each one is quoted from the notice.
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.
Matched against the notice text, so this is a floor — the tender pack will demand things the notice never mentions. “Says must” means the quoted sentence itself used obligation language; anything ambiguous is left as a mention.
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- OCID
- ocds-h6vhtk-06b95e
- Stage
- award · Awarded
- Source
- Find a Tender
- Buyer ref
- 058183-2026
Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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