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.