Medical Devices — Application of Risk Management to Medical Devices
The international standard specifying a process for medical-device manufacturers to identify hazards, estimate and evaluate risks, control them, and monitor the effectiveness of controls across the device lifecycle. The 2019 edition strengthened benefit-risk analysis and production/post-production feedback.
Medical-device and IVD manufacturers. Harmonised under the EU MDR/IVDR and referenced alongside ISO 13485 quality systems.
- 01Maintain a risk management file across the device lifecycle
- 02Evaluate overall residual risk and benefit-risk
- 03Feed production and post-production data back into risk management
The 2019 edition strengthened benefit-risk analysis and production/post-production information; ISO/TR 24971:2020 provides guidance.
ISO 14971:2019: frequently asked questions
Quick answers to common questions about ISO 14971:2019.
What is ISO 14971:2019?
ISO 14971:2019 — Medical Devices — Application of Risk Management to Medical Devices — is a standard issued by the International Organization for Standardization. The international standard specifying a process for medical-device manufacturers to identify hazards, estimate and evaluate risks, control them, and monitor the effectiveness of controls across the device lifecycle. The 2019 edition strengthened benefit-risk analysis and production/post-production feedback.
Who does ISO 14971:2019 apply to?
Medical-device and IVD manufacturers. Harmonised under the EU MDR/IVDR and referenced alongside ISO 13485 quality systems.
What are the key requirements of ISO 14971:2019?
ISO 14971:2019 requires, among other things: Maintain a risk management file across the device lifecycle; Evaluate overall residual risk and benefit-risk; Feed production and post-production data back into risk management.
When was ISO 14971:2019 last updated?
The current version of ISO 14971:2019 dates from December 2019. The 2019 edition strengthened benefit-risk analysis and production/post-production information; ISO/TR 24971:2020 provides guidance.
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