Language:
-
- Available Formats
- Options
- Availability
- Priced From ( in USD )
-
- Immediate download
- $250.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $288.00
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- $383.00
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 15225:2016
Priced From $103.00 -
ISO 13488:1996
Priced From $54.00 -
ISO 16142-1:2016
Priced From $200.00 -
ISO 14971:2019
Priced From $185.00
About This Item
Full Description
ISO/TR 24971:2020 provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
Document History
-
ISO/TR 24971:2020 Plus Redline
Medical devices - Guidance on the application of ISO 14971- Historical Version
-
ISO/TR 24971:2020
currently
viewing
Medical devices - Guidance on the application of ISO 14971- Most Recent
-
ISO/TR 24971:2013
Medical devices - Guidance on the application of ISO 14971- Historical Version