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Regulatory Compliance Services for Medical Devices

NHS England

This public procurement record has 1 release in its history.

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23 Sep 2026 at 17:27

UK7 - Contract Details Notice
Summary of the contracting process

NHS England commissioned specialist regulatory compliance consultancy for medical devices. The work supports achievement of ISO 13485 certification, which the buyer describes as critical to developing and deploying higher-risk software and artificial intelligence medical devices, including its planned Probabilistic AI Triage product. It also supports the continued development of the organisation’s quality management system and continuity of regulatory, quality and medical-device activities. The requirement is for research and development consultancy services related to medical-device regulation and quality management. The supplier is DevicePharm Consultancy Limited, based in London; the procurement data does not identify a delivery location, so no work site can be inferred.

The procurement is complete and awarded, with an active contract signed with DevicePharm Consultancy Limited. NHS England used a direct award below the applicable threshold, without competition. The contract was signed on 18 September 2026 and runs from 28 September to 31 December 2026. Its value is £99,500 excluding VAT (£119,400 including VAT). The requirement was structured as one lot, and the award relates to that lot. The published procurement details identify the service and selected supplier but provide no evaluation criteria or scoring basis to report.

For suppliers looking to compete for comparable NHS England work, this award demonstrates demand for consultancy that can help secure ISO 13485 certification and support regulatory compliance for higher-risk medical-device software and AI. Credible providers would need practical expertise in medical-device quality systems, regulatory requirements and certification, together with the ability to work alongside NHS England on product development and deployment, including probabilistic AI triage. The stated need for continuity of expertise and retention of organisational knowledge also points to the value of sustained engagement and an understanding of the buyer’s existing quality management arrangements. This was a single, focused consultancy requirement awarded directly without competition; the record gives no supplier qualification or capacity requirements to indicate additional barriers to entry.

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Notice Information

Notice Title

Regulatory Compliance Services for Medical Devices

Notice Description

Support in respect of the achievement of ISO 13485 certification, a critical requirement for the development and deployment of higher-risk software and AI medical devices, including the planned Probabilistic AI Triage product. The service is essential to ensure continuity of expertise, retain critical organisational knowledge built over the last two years, and avoid delays to regulatory, quality and medical device activities. The proposed arrangement will provide business continuity, support the continued maturity of the Quality Management System,

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-077905
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/090336-2026
Current Stage
Award
All Stages
Award

Procurement Classification

Notice Type
UK7 - Contract Details Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Direct
Procurement Method Details
Below threshold - without competition
Tender Suitability
Not specified
Awardee Scale
Large

Common Procurement Vocabulary (CPV)

CPV Divisions

73 - Research and development services and related consultancy services

CPV Codes

73000000 - Research and development services and related consultancy services

73200000 - Research and development consultancy services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
£99,500 Under £100K

Notice Dates

Publication Date
23 Sep 20261 weeks ago
Submission Deadline
Not specified
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
28 Sep 2026 - 31 Dec 2026 1-6 months
Recurrence
Not specified

Notice Status

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

Buyer & Supplier

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
Postcode Area
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

DevicePharm Consultancy Limited

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

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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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