---
title: "Medical device regulatory compliance"
ocid: "ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3.json"
source: "Contracts Finder"
current_stage: "Award"
buyer: "NHS ENGLAND"
published: "2025-03-26"
---

# Medical device regulatory compliance

Buyer: NHS ENGLAND  
Current stage: Award  
OCID: ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3

[View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3)  
[Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3.json)

## Summary

NHS England has awarded a contract for regulatory compliance services related to updating software medical device products. The project involves testing, validation, and technical documentation to align with amended regulatory requirements. The procurement process was conducted through an open procedure below the threshold and falls under the category of "System quality assurance assessment and review services" with additional classification for "Repair and maintenance services of medical and surgical equipment". The contract value is £110,000, with service delivery set to commence on 11th November 2024 and conclude on 1st March 2026. The contracting authority's location is Leeds, England, and the tender was completed in the award stage, with the final award being published on 26th March 2025.

Businesses specialising in medical device compliance, testing, and maintenance services, particularly SMEs, have significant growth opportunities with this tender. The open procurement method invites competitive bids from qualified firms, allowing for broad participation and fair competition. This project offers a substantial contract worth £110,000 over a period of nearly two years, making it an attractive venture for enterprises capable of delivering high-quality validation and documentation services to meet NHS England's regulatory compliance needs.

## Notice

Updating NHS-E software medical device products' testing, validation and technical documentation to bring the products in line with the expected requirements of the amended regulation.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/f5caa24f-0a8b-49c3-8d7b-81e29a01b603 |
| Notice type | Award Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Open |
| Procurement method details | Open procedure (below threshold) |
| Tender suitability | SME |
| Awardee scale | SME |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 26 Mar 2025 |
| Submission deadline | 24 Oct 2024 |
| Future notice date | Not specified |
| Award date | 7 Nov 2024 |
| Contract period | 11 Nov 2024 - 1 Mar 2026 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £110,000 |
| Lots value | Not specified |
| Awards value | £110,000 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Not specified |
| Awards status | Active |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | NHS ENGLAND |
| Locality | LEEDS |
| Post town | Leeds |
| Postcode | LS1 4AP |
| Country | England |
| ITL 1 | TLE Yorkshire and The Humber |
| ITL 2 | TLE4 West Yorkshire |
| ITL 3 | TLE42 Leeds |
| Local authority | Leeds |
| Electoral ward | Hunslet & Riverside |
| Westminster constituency | Leeds South |
| Delivery location | TLC North East (England), TLD North West (England), TLF East Midlands (England), TLG West Midlands (England), TLH East (England), TLJ South East (England), TLK South West (England) |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | DEVICEPHARM CONSULTANCY |

## CPV Codes

### Divisions

- 50 - Repair and maintenance services
- 72 - IT services: consulting, software development, Internet and support

### Codes

- 50420000 - Repair and maintenance services of medical and surgical equipment
- 72225000 - System quality assurance assessment and review services

## Release History

- 26 Mar 2025 at 11:12 - Award - Award Notice - https://www.contractsfinder.service.gov.uk/Notice/f5caa24f-0a8b-49c3-8d7b-81e29a01b603

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/f5caa24f-0a8b-49c3-8d7b-81e29a01b603
  26th March 2025 - Awarded contract notice on Contracts Finder
- https://www.contractsfinder.service.gov.uk/Notice/Attachment/fa5854f7-42cd-4b91-a4ef-b354920c867a
  NHS_TERMS_AND_CONDITIONS_FOR_THE_PROVISION_OF_SERVICES__PO_VERSION_

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3.json.