The University of Edinburgh seeks a supplier to develop a production version of its heart-attack diagnosis software, requiring expertise in medical device software development and adherence to regulatory standards.
Creation of software application classed as medical device. The University of Edinburgh has developed a novel algorithm which may improve the accuracy of heart-attack diagnosis in the emergency department. A prototype of this software has been developed. The objective of this procurement is to identify a supplier to create a productionised version of this software tool, which for regulatory purposes in the UK, USA and EU would be classified as a ‘Medical Device’. Such a supplier will have exceptional competence in software development, and prior experience in creation of software classed as a ‘Medical Device’. The supplier will be expected to (but not limited to…); Demonstrate their prior expertise via example projects and references Utilise modern, reliable, and maintainable programming language/s, frameworks and components to deliver the project. Operate a quality management system in line with ISO13485 and follow any and all relevant guidance set by medical regulatory bodies in the UK, EU and USA in relation to production of software classed as a ‘medical device’ Utilise test-oriented development and design and deliver a test strategy for the development Operate a sophisticated project management approach and transparent progress reporting and governing to maximise potential success of the project Demonstrate how they will manage risk and uncertainty to ensure the project falls explicitly within the cost appetite Be open to regulatory audit, if required, by a medical regulator in the UK, EU or USA; or, by a third party acting for the University for regulatory outcomes, which may include desktop review or site visit The University anticipates awarding a Master Services Agreement to set the basis of the engagement and an initial engagement Statement of Work for the creation, testing and regulatory approval.
Short summary Creation of software application classed as medical device. The University of Edinburgh has developed a novel algorithm which may improve the accuracy of heart-attack diagnosis in the emergency department. A prototype of this software has been developed. The objective of this procurement is to identify a supplier to create a productionised version of this software tool, which for regulatory purposes in the UK, USA and EU would be classified as a ‘Medical Device’. Such a supplier will have exceptional competence in software development, and prior experience in creation of software classed as a ‘Medical Device’. The supplier will be expected to (but not limited to…); Demonstrate their prior expertise via example projects and references Utilise modern, reliable, and maintainable programming language/s, frameworks and components to deliver the project. Operate a quality management system in line with ISO13485 and follow any and all relevant guidance set by medical regulatory bodies in the UK, EU and USA in relation to production of software classed as a ‘medical device’ Utilise test-oriented development and design and deliver a test strategy for the development Operate a sophisticated project management approach and transparent progress reporting and governing to maximise potential success of the project Demonstrate how they will manage risk and uncertainty to ensure the project falls explicitly within the cost appetite Be open to regulatory audit, if required, by a medical regulator in the UK, EU or USA; or, by a third party acting for the University for regulatory outcomes, which may include desktop review or site visit The University anticipates awarding a Master Services Agreement to set the basis of the engagement and an initial engagement Statement of Work for the creation, testing and regulatory approval. The estimated value of the tender represents an initial cost appetite of GBP180k (including VAT) (which the University may review from time to time), with contingency for potential additional work packages over the maximum term of the agreement. The estimate does not reflect an offer or promise of business above any contract which is ultimately signed by the parties. AI Policy; Due to the proprietary nature of the IP in this engagement and the human-safety implications of this technology; A.The supplier at no time will be permitted to expose or query any part of the IP the University provides to the supplier to any public facing/internet connected AI system (including but not limited to ChatGPT, Grok, Claude etc.). Any other automated system is only to be used with permission of the University and with proper transparency about how it operates and is isolated from potential data harvesting or exfiltration. B.The supplier shall not utilise any other AI to automatically generate the code base or any substantial part of it. (i.e. ‘Vibe coding’) C.AI must not be utilised in the core logic, the app must be deterministic D.The supplier shall be required to undertake human code review and resilience checking in addition to any automated tools The complete requirements are set out in the procurement documentation. Award The University anticipates awarding a Master Services Agreement contract with a supplier for software development services for a period of 5 years, and an initial statement of work for the development of the productionised software product and supporting this through regulatory approvals. Variation and options The University reserves the right to award additional work packages to the winning Tenderer via the Negotiated Procedure Without Prior Call for Competition