# 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