Medical devices Archives - AI Standards Hub

The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the…

Published

Last Updated: 18 Jul 2024

BS 34971/AAMI CR 34971

Application of ISO 14971 to machine learning in artificial intelligence. Guide

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Healthcare and medicine - Medical devices AI-specific Data protection Organisational governance

Risk management Security and resilience Process, management and governance

What is BS AAMI 34971 – Application of ISO 14971 to machine learning in artificial intelligence – Guide about? Artificial…

Published

Last Updated: 18 Jul 2024

Strategies and roadmaps

Roadmap towards the future regulatory framework for medical devices

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Domain:

Healthcare and medicine - Medical devices

“This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 29 Feb 2024

Regulation and official guidance

Software and artificial intelligence (AI) as a medical device

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Topic:

Safety

Domain:

Healthcare and medicine - Medical devices

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

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Topic:

Safety Trustworthy AI

Domain:

Healthcare and medicine - Medical devices

Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…

Organisation: Medicine & Healthcare products Regulatory Authority

Last Updated: 30 May 2023

Research and analysis item

Recent advancements in AI – implications for medical device technology and certification

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Topic:

Assurance and testing Standardisation for AI

Domain:

Healthcare and medicine - Medical devices

Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why…

Last Updated: 21 Nov 2022

Research and analysis item

The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation

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Topic:

Assurance and testing Standardisation for AI

Domain:

Healthcare and medicine - Medical devices

The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…

Last Updated: 21 Nov 2022

Research and analysis item

Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance

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Topic:

Assurance and testing Standardisation for AI

Domain:

Healthcare and medicine - Medical devices

The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…

Last Updated: 21 Nov 2022

Regulation and official guidance

Guidance: medical device stand-alone software including apps

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Topic:

Good practice for development and use Safety

Domain:

Healthcare and medicine - Medical devices

Information on when software applications are considered to be a medical device and how they are regulated. This content is…

Last Updated: 12 Oct 2022

Regulation and official guidance

Digital technology assessment criteria (DTAC)

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Topic:

Assurance and testing Data protection Procurement Safety Security and resilience

Domain:

Healthcare and medicine - Medical devices

The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital…

Last Updated: 12 Oct 2022

Content Type

Information technology – Brain-computer Interfaces – Vocabulary

The Use of Artificial Intelligence in Health Care: Trustworthiness

Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology

Application of ISO 14971 to machine learning in artificial intelligence. Guide

Roadmap towards the future regulatory framework for medical devices

Software and artificial intelligence (AI) as a medical device

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

Recent advancements in AI – implications for medical device technology and certification

The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation

Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance

Guidance: medical device stand-alone software including apps

Digital technology assessment criteria (DTAC)

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