Planning

Quality Management System (MDR Compliance)

THE COMMON SERVICES AGENCY (MORE COMMONLY KNOWN AS NHS NATIONAL SERVICES SCOTLAND) ("NSS")

This public procurement record has 1 release in its history.

Planning

11 May 2022 at 00:00

OJEU - F1 - Prior Information Notice
Summary of the contracting process

The Common Services Agency, commonly known as NHS National Services Scotland (NSS), is seeking to establish a Quality Management System (QMS) to ensure compliance with UK Medical Device Regulations. This tender, titled "Quality Management System (MDR Compliance)", is currently in the planning stage, with a future notice expected on 1st September 2023. The procurement primarily falls under the health industry category and will be conducted within Scotland, specifically pertaining to services associated with medical device management. The pertinent details can be found in associated documents published on 11th May 2022.

This tender presents significant opportunities for businesses specialising in electronic Quality Management Systems, particularly those that can offer innovative solutions compliant with ISO 13485 standards. Companies engaged in health tech, software development, and compliance consulting would be particularly well-positioned to compete for this contract, as NSS is exploring contemporary capabilities to enhance operational efficiency and patient safety. Suppliers are encouraged to monitor upcoming communications and provide insightful feedback to inform NSS's procurement strategy.

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Notice Information

Notice Title

Quality Management System (MDR Compliance)

Notice Description

NSS occupies a unique place in the delivery of Health and Social Care across Scotland in that it manufactures (as defined by the MHRA), owns, manages, procures, maintains, uses, stores and disposes a large variety of Medical Devices (both hardware and software), which are subject to the UK Medical Device Regulations. As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required. While the regulations do not define the nature of the Quality Management System (QMS), which may be paper based or electronic, NSS is interested in discovering available electronic QMS solutions that will complement the QMS processes.

Lot Information

Lot 1

NHS Scotland is exploring all the available options of Quality Management Systems to ensure compliance with the new and evolving requirements of the Regulations. The objective of this exercise is to obtain up-to-date information and feedback from the market in order to: Understand the capabilities and solutions in relation to the functionality and usability required; Understand where innovation and the "state of the art" may provide opportunities for NSS to improve efficiency, effectiveness and Patient Safety; and Provide NSS with a deployment overview and indicative costs associated with the implementation and on-going support of a suitable solution The information to be provided will help us better understand the market and consider the way forward. Views and suggestions will not be disclosed to third parties or used for any other purpose.. For further information please review the attached document titled 'MDR Compliance QMS PIN v.1.0'

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-r6ebe6-0000692447
Publication Source
Public Contracts Scotland
Latest Notice
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY448091
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
OJEU - F1 - Prior Information Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
Not specified
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

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

CPV Codes

72000000 - IT services: consulting, software development, Internet and support

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
11 May 20223 years ago
Submission Deadline
Not specified
Future Notice Date
1 Sep 2023Expired
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Planned
Lots Status
Planned
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
THE COMMON SERVICES AGENCY (MORE COMMONLY KNOWN AS NHS NATIONAL SERVICES SCOTLAND) ("NSS")
Contact Name
Not specified
Contact Email
patrick.mulraney@nhs.scot
Contact Phone
+44 1698794410

Buyer Location

Locality
EDINBURGH
Postcode
EH12 9EB
Post Town
Edinburgh
Country
Scotland
Major Region (ITL 1)
TLM Scotland
Basic Region (ITL 2)
TLM1 East Central Scotland
Small Region (ITL 3)
TLM13 City of Edinburgh
Delivery Location
TLM Scotland
Local Authority
City of Edinburgh
Electoral Ward
Drum Brae/Gyle
Westminster Constituency
Edinburgh South West

Further Information

Notice Documents

  • https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY448091
    Quality Management System (MDR Compliance) - NSS occupies a unique place in the delivery of Health and Social Care across Scotland in that it manufactures (as defined by the MHRA), owns, manages, procures, maintains, uses, stores and disposes a large variety of Medical Devices (both hardware and software), which are subject to the UK Medical Device Regulations. As part of the process to achieve and maintain compliance with the Regulations, a Quality Management System (consistent with ISO 13485) is required. While the regulations do not define the nature of the Quality Management System (QMS), which may be paper based or electronic, NSS is interested in discovering available electronic QMS solutions that will complement the QMS processes.

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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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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