Research and analysis item
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Research and analysis item
Better, broader, safer: using health data for research and analysis
Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
This British Standard specifies requirements for the development of safe, effective, and ethical healthcare AI products. This British Standard specifies…
Research and analysis item
Standardization empowering AI-enabled systems in healthcare – workshop report
Research and analysis item
Connected and autonomous plant – a roadmap to 2035
Research and analysis item
Recent advancements in AI – implications for medical device technology and certification
Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why…
Research and analysis item
The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
Research and analysis item
Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance
The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and…
Research and analysis item
Connected and automated vehicles: a review of the UK’s legislation and good practice
The white paper provides an overview of the CCAV Code of Practice (CoP): Automated Vehicle Trialling, BSI’s CAV standards programme,…
Research and analysis item
Connected and automated vehicle (CAV) standards roadmap 2022
The roadmap is intended to help users visualize the emerging standards landscape for automated driving and key standards relevant to…
