What is PD CEN ISO/TS 24971-2 ED1 - Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence about?
PD CEN ISO/TS 24971-2 Edition 1 gives you guidance on how to apply the BS EN ISO 14971 Medical devices — Application of risk management to medical devices to machine learning-enabled medical devices. It explains the risks that machine learning can introduce, including issues linked to training data, bias, explainability, transparency, autonomy, cybersecurity, model drift and continuous learning.
PD CEN ISO/TS 24971-2 ED1 is designed to supplement existing medical device risk management standards, so you can address machine learning-specific issues across development, testing, deployment, retraining and post-production monitoring. The standard is intended to be used alongside BS EN ISO 14971. It also builds on the general guidance in PD CEN ISO/TR 24971 by addressing risk management challenges unique to machine learning-enabled medical devices. It provides practical guidance on topics such as bias, training and test data, explainability, transparency, model drift, continuous learning, retraining and autonomy that are not covered in the same depth by existing risk management guidance.
Who is PD CEN ISO/TS 24971-2 ED1 - Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence for?
This publication is relevant if you develop, assess, manage, or review machine learning-enabled medical devices. It is particularly useful for:
Risk management professionals in medical device manufacturing.
Regulatory affairs specialists.
Software and AI/ML engineers.
Clinical safety and usability experts, including human factors specialists.
Quality assurance professionals.
Product managers and device developers....
Open preview (PDF)Medical devices. Guidance on the application of ISO 14971 - Machine learning in artificial intelligence