Award

Medical device regulatory compliance

NHS ENGLAND

This public procurement record has 1 release in its history.

Award

26 Mar 2025 at 11:12

Summary of the contracting process

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.

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Notice Title

Medical device regulatory compliance

Notice Description

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.

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-78216b60-8212-4a9a-914d-a3daecac65f3
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/f5caa24f-0a8b-49c3-8d7b-81e29a01b603
Current Stage
Award
All Stages
Award

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

50 - Repair and maintenance services

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


CPV Codes

50420000 - Repair and maintenance services of medical and surgical equipment

72225000 - System quality assurance assessment and review services

Notice Value(s)

Tender Value
£110,000 £100K-£500K
Lots Value
Not specified
Awards Value
£110,000 £100K-£500K
Contracts Value
Not specified

Notice Dates

Publication Date
26 Mar 202511 months ago
Submission Deadline
24 Oct 2024Expired
Future Notice Date
Not specified
Award Date
7 Nov 20241 years ago
Contract Period
11 Nov 2024 - 1 Mar 2026 1-2 years
Recurrence
Not specified

Notice Status

Tender Status
Complete
Lots Status
Not Specified
Awards Status
Active
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
NHS ENGLAND
Contact Name
Pratim Saikia
Contact Email
pratim.saikia@nhs.net
Contact Phone
Not specified

Buyer Location

Locality
LEEDS
Postcode
LS1 4AP
Post Town
Leeds
Country
England

Major Region (ITL 1)
TLE Yorkshire and The Humber
Basic Region (ITL 2)
TLE4 West Yorkshire
Small Region (ITL 3)
TLE42 Leeds
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)

Local Authority
Leeds
Electoral Ward
Hunslet & Riverside
Westminster Constituency
Leeds South

Supplier Information

Number of Suppliers
1
Supplier Name

DEVICEPHARM CONSULTANCY

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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