Regulatory Compliance Services for Medical Devices

Notice Information

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Notice Title

Notice 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

Notice Details

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Publication & Lifecycle

Open Contracting ID: ocds-h6vhtk-06b95e
Publication Source: Find A Tender Service
Latest Notice: https://www.find-tender.service.gov.uk/Notice/058183-2026
Current Stage: Award
All Stages: Award

Procurement Classification

Notice Type: UK7 - Contract Details Notice
Procurement Type: Standard
Procurement Category: Services
Procurement Method: Limited
Procurement Method Details: Below threshold - limited competition
Tender Suitability: Not specified
Awardee Scale: Large

Common Procurement Vocabulary (CPV)

CPV Divisions: 85 - Health and social work services
CPV Codes: 85100000 - Health services

Notice Value(s)

Tender Value: Not specified
Lots Value: Not specified
Awards Value: Not specified
Contracts Value: £75,000 Under £100K

Notice Dates

Publication Date: 19 Jun 20265 days ago
Submission Deadline: Not specified
Future Notice Date: Not specified
Award Date: 1 Jun 20263 weeks ago
Contract Period: 1 Jun 2026 - 31 Mar 2027 6-12 months
Recurrence: Not specified

Notice Status

Tender Status: Complete
Lots Status: Complete
Awards Status: Active
Contracts Status: Active

Buyer & Supplier

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Contracting Authority (Buyer)

Main Buyer: NHS ENGLAND
Contact Name: Available with D3 Tenders Premium →
Contact Email: Available with D3 Tenders Premium →
Contact Phone: Available with D3 Tenders Premium →

Buyer Location

Locality: LONDON
Postcode: SE1 8UG
Post Town: South East London
Country: England
Major Region (ITL 1): TLI London
Basic Region (ITL 2): TLI4 Inner London - East
Small Region (ITL 3): TLI45 Lambeth
Delivery Location: Not specified
Local Authority: Lambeth
Electoral Ward: Waterloo & South Bank
Westminster Constituency: Vauxhall and Camberwell Green

Supplier Information

Number of Suppliers: 1
Supplier Name: SCARLET GLOBAL HOLDINGS

Further Information

Notice Documents

https://www.find-tender.service.gov.uk/Notice/058183-2026
19th June 2026 - Contract details notice on Find a Tender

Notice URLs

Open Contracting Data Standard (OCDS)

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JSON Markdown

The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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