Medical devices Archives - Page 2 of 5

The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action…

Last Updated: 12 Oct 2022

Strategies and roadmaps

Software and AI as a medical device change programme

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Topic:

Assurance and testing Safety

Domain:

Healthcare and medicine - Medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical…

Last Updated: 19 Dec 2022

Official policy proposals and consultations

Consultation on the future regulation of medical devices in the United Kingdom

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Topic:

Assurance and testing Explainability and transparency Safety

Domain:

Healthcare and medicine - Medical devices

Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory…

Last Updated: 15 Dec 2022

Regulation and official guidance

A guide to good practice for digital and data-driven health technologies

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Topic:

Adoption and commercialisation Assurance and testing Ethical considerations Good practice for development and use Procurement

Domain:

Healthcare and medicine - Medical devices

This guide is designed to support innovators in understanding what the NHS is looking for when it buys digital and…

Last Updated: 15 Dec 2022

Regulation and official guidance

A buyer’s guide to AI in health and care

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Topic:

Adoption and commercialisation Assurance and testing Ethical considerations Procurement

Domain:

Healthcare and medicine - Medical devices

The exciting promise of artificial intelligence (AI) to transform areas of health and care is becoming a reality. Prospective vendors…

Last Updated: 12 Oct 2022

Frameworks and principles

Evidence standards framework (ESF) for digital health technologies

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Topic:

Assurance and testing Good practice for development and use Standardisation for AI

Domain:

Healthcare and medicine - Medical devices

Last Updated: 12 Oct 2022

Strategies and roadmaps

Artificial intelligence: how to get it right

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Topic:

Accountability Adoption and commercialisation Data Ethical considerations Safety

Domain:

Healthcare and medicine - Medical devices

Artificial Intelligence (AI) has the potential to make a significant difference to health and care. A broad range of techniques…

Last Updated: 12 Oct 2022

Frameworks and principles

Deliverable 1: principles for the evaluation of artificial intelligence or machine learning-enabled medical devices to assure safety, effectiveness and ethicality

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Topic:

Assurance and testing Ethical considerations Good practice for development and use

Domain:

Healthcare and medicine - Medical devices

As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…

Last Updated: 19 Dec 2022

Frameworks and principles

Deliverable 2: principles to support the development and deployment of artificial intelligence or machine learning-enabled medical devices across jurisdictions

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Topic:

Assurance and testing

Domain:

Healthcare and medicine - Medical devices

As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…

Last Updated: 19 Dec 2022

Content Type

Guidance: medical device stand-alone software including apps

Digital technology assessment criteria (DTAC)

Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan

Software and AI as a medical device change programme

Consultation on the future regulation of medical devices in the United Kingdom

A buyer’s guide to AI in health and care

Evidence standards framework (ESF) for digital health technologies

Artificial intelligence: how to get it right

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