---
title: "Quality Management System (MDR Compliance)"
ocid: "ocds-r6ebe6-0000692447"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-r6ebe6-0000692447"
markdown_url: "https://d3tenders.com/contract/ocds-r6ebe6-0000692447.md"
json_url: "https://d3tenders.com/contract/ocds-r6ebe6-0000692447.json"
source: "Public Contracts Scotland"
current_stage: "Planning"
buyer: "THE COMMON SERVICES AGENCY (MORE COMMONLY KNOWN AS NHS NATIONAL SERVICES SCOTLAND) (\"NSS\")"
published: "2022-05-11"
---

# Quality Management System (MDR Compliance)

Buyer: THE COMMON SERVICES AGENCY (MORE COMMONLY KNOWN AS NHS NATIONAL SERVICES SCOTLAND) ("NSS")  
Current stage: Planning  
OCID: ocds-r6ebe6-0000692447

[View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-r6ebe6-0000692447)  
[Download OCDS JSON](https://d3tenders.com/contract/ocds-r6ebe6-0000692447.json)

## Summary

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.

## Notice

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'

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Public Contracts Scotland |
| Latest notice | https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY448091 |
| 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 |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 11 May 2022 |
| Submission deadline | Not specified |
| Future notice date | 1 Sep 2023 |
| Award date | Not specified |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Planned |
| Lots status | Planned |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | THE COMMON SERVICES AGENCY (MORE COMMONLY KNOWN AS NHS NATIONAL SERVICES SCOTLAND) ("NSS") |
| Locality | EDINBURGH |
| Post town | Edinburgh |
| Postcode | EH12 9EB |
| Country | Scotland |
| ITL 1 | TLM Scotland |
| ITL 2 | TLM1 East Central Scotland |
| ITL 3 | TLM13 City of Edinburgh |
| Local authority | City of Edinburgh |
| Electoral ward | Drum Brae/Gyle |
| Westminster constituency | Edinburgh South West |
| Delivery location | TLM Scotland |

## CPV Codes

### Divisions

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

### Codes

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

## Release History

- 11 May 2022 at 00:00 - Planning - OJEU - F1 - Prior Information Notice - https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY448091

## Documents

- https://www.publiccontractsscotland.gov.uk/NoticeDownload/DownloadDocument.aspx?id=MAY448091&idx=1
  11th May 2022 - MDR QMS Pin
- 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.

## Notice URLs

- http://
- http://www.nss.nhs.scot/browse/procurement-and-logistics
- http://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=692447
- https://api.publiccontractsscotland.gov.uk/v1/Notice?id=ocds-r6ebe6-0000692447

## 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-r6ebe6-0000692447. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-r6ebe6-0000692447.json.