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ISO/TR 24971:2020
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| Price | Price USD 239.00 | ||
| Rating | Rating | ||
| Buy | Buy Add to Cart | ||
| Description |
Description
This document 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. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25]. |
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| Standard Number | Standard Number ISO/TR 24971:2020 | ||
| Title | Title ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971 | ||
| Status | Status Published | ||
| Publication Date | Publication Date 16 Jun 2020 | ||
| Cross References | Cross References | ||
| Descriptors | Descriptors | ||
| ICS | ICS 11.040.01 | ||
| Committee | Committee ISO/TC 210 Quality management and corresponding general aspects for medical devices | ||
| ISBN | ISBN | ||
| Publisher | Publisher PECB Store | ||
| Format | Format PDF | ||
| Delivery | Delivery NO | ||
| Pages | Pages 87 | ||
| File Size | File Size KB |
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