Quality Management System (MDR Compliance)

Tender 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 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. Additional information: For further information please review the attached document titled 'MDR Compliance QMS PIN v.1.0'