Medical Device Risk Management File
Device risk mgmt file – benefit-risk analysis
사용법: Risk = severity x probability of HARM (injury), not business risk. Benefit-risk analysis for residual risks is the section commercial risk registers don't have.
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Medical Device Risk Management File
ISO 14971:2019 – the device-specific risk process. Distinct from generic risk register: harm = physical injury/health damage, and risk acceptability weighs residual risk vs clinical benefit.
| Field | Value |
|---|---|
| Device | name + intended use |
| File ID | RMF-NNN |
| Policy | risk acceptability criteria ref |
| Responsible | risk management lead |
1. Intended use & foreseeable misuse
- Intended use, user profile, use environment
- Reasonably foreseeable misuse scenarios
2. Hazard identification
| ID | Hazard | Foreseeable sequence | Hazardous situation | Harm |
|---|---|---|---|---|
| HZ-01 | Electrical leakage | insulation failure + contact | patient contact | shock |
| HZ-02 | Software fault | incorrect dose calculation | over/under dose | injury |
| HZ-03 | Sterility breach | packaging failure | contaminated device | infection |
3. Risk estimation & evaluation
| ID | Severity (1-5) | Probability (1-5) | Risk | Acceptable? |
|---|---|---|---|---|
| HZ-01 | 4 | 2 | 8 | No – treat |
| HZ-02 | 5 | 2 | 10 | No – treat |
| HZ-03 | 4 | 1 | 4 | Accept w/ controls |
4. Risk controls (priority order: inherent safety → protective
measures → information for safety)
| ID | Control type | Control implemented | Residual P | Residual risk | Acceptable? |
|---|---|---|---|---|---|
| HZ-01 | Inherent | double insulation | 1 | 4 | Yes |
| HZ-02 | Protective | independent dose check | 1 | 5 | Yes |
| HZ-03 | Information | sterile barrier + label | 1 | 4 | Yes |
5. Benefit-risk analysis (residual risks not further reducible)
- Medical benefit of device vs each residual risk
- Conclusion: benefits outweigh residual risks? – documented judgment
6. Overall residual risk acceptability
Combined residual risk across all hazards vs benefits – management sign-off required.
7. Production & post-production information
- Complaints, vigilance reports, PMS data feeding back into risk file
- Risk file is LIVING – updated through the device lifecycle