Compliance auditISO 14971:2019
ISO 14971:2019 — Risk management for medical devices
Application of risk management to medical devices: risk analysis, evaluation and control, overall residual risk, and production and post-production activities.
- control points
- 50
- anchored clauses
- 21
- Clauses covered
- 7
Clauses covered
| Risk management system | 5 | 4.1 · 4.2 · 4.3 · 4.4 · 4.5 |
| Risk analysis | 4 | 5.2 · 5.3 · 5.4 · 5.5 |
| Risk evaluation | 1 | 6 |
| Risk control | 6 | 7.1 · 7.2 · 7.3 · 7.4 · 7.5 · 7.6 |
| Overall residual risk | 1 | 8 |
| Risk management review | 1 | 9 |
| Production and post-production activities | 3 | 10.2 · 10.3 · 10.4 |
Scale
CompliantOpportunity for improvementNon-compliantNot applicable
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