This tender is from the country of United Kingdom in Europe region. The tender was published by University Of Edinburgh on 26 Sep 2025 for Heart Attack Diagnosis Software DevelopmentCreation 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 last date to submit your bid for this tender was 24 Oct 2025. This tender is for the companies specializing in Medical software package and similar sectors.
*The deadline for this tender has passed.
Tender Organisation:
University Of Edinburgh
Tender Sector:
Tender Service:
Worldwide
Tender Region:
Tender Country:
Tender CPV:
48180000 : Medical software package
Tender Document Type:
Tender Notice
Tender Description:
Heart Attack Diagnosis Software DevelopmentCreation 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
Tender Bidding Type:
Tender Notice No:
Tender Document:
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