Section one: Contracting authority
one.1) Name and addresses
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Edinburgh
EH12 9EB
Contact
Ope Ore
Telephone
+44 7866157482
Country
United Kingdom
NUTS code
UKM - Scotland
Internet address(es)
Main address
http://www.nss.nhs.scot/browse/procurement-and-logistics
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA11883
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
Additional information can be obtained from the above-mentioned address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Quality Management System (MDR Compliance)
Reference number
NP605721
two.1.2) Main CPV code
- 72000000 - IT services: consulting, software development, Internet and support
two.1.3) Type of contract
Services
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 72000000 - IT services: consulting, software development, Internet and support
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
Scotland
two.2.4) Description of the procurement
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.
two.2.14) Additional information
For further information please review the attached document titled 'MDR Compliance QMS PIN v.1.0'
two.3) Estimated date of publication of contract notice
1 September 2023
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section six. Complementary information
six.3) Additional information
NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=692447.
(SC Ref:692447)