Regulation and official guidance
Guidance on GxP data integrity
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…
Healthcare and medicine
Regulation and official guidance
Software and artificial intelligence (AI) as a medical device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
Research and analysis item
Accelerating effective and safe adoption of artificial intelligence in the healthcare system
Artificial intelligence (AI) – algorithms with the ability to perform tasks that would normally require human intelligence – has great…
Research and analysis item
Accelerating effective and safe adoption of artificial intelligence in the healthcare system
Artificial intelligence (AI) – algorithms with the ability to perform tasks that would normally require human intelligence – has great…
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…
PAS 277:2015 from BSI
Health and wellness apps. Quality criteria across the life cycle. Code of practice
What is PAS 277 – Health and wellness apps – Code of practise with quality standards for all stages of…
EN ISO 13482:2014
BS EN ISO 13482:2014
Robots and robotic devices. Safety requirements for personal care robots
What is this standard about? It supplies the latest guidelines and specifications to ensure the safe design and use of…
ISO/TS 22272:2021
PD ISO/TS 22272:2021
Health Informatics. Methodology for analysis of business and information needs of health enterprises to support standards based architectures
What is ISO/TS 22272 about? PD ISO/TS 22272 presents a methodology that supports and enables the development of standards-based business…
The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the…
