---
title: "Healthcare"
description: "TraceRTM for healthcare and medical device traceability"
keywords: [healthcare, medical devices, fda, compliance, regulatory]
---

# Healthcare

Using TraceRTM for requirements traceability in healthcare and medical devices.

## Regulatory Compliance

### FDA 21 CFR Part 820

```python
# Track FDA requirements
fda_req = client.items.create(
    title="FDA 21 CFR 820.30 Design Controls",
    view="requirements",
    metadata={"regulation": "FDA 21 CFR Part 820"}
)

# Link design documents
design = client.items.create(
    title="Medical Device Design Document",
    view="design"
)

client.links.create(
    source_id=design.id,
    target_id=fda_req.id,
    link_type="complies_with"
)
```

### ISO 13485

```python
# ISO 13485 requirements
iso_req = client.items.create(
    title="ISO 13485:2016 Quality Management",
    view="requirements",
    metadata={"standard": "ISO 13485:2016"}
)
```

## Medical Device Development

### Requirements to Verification

1. **Clinical Requirements**
   ```python
   clinical_req = client.items.create(
       title="Clinical Requirement: Safety",
       view="requirements"
   )
   ```

2. **Verification Tests**
   ```python
   verification = client.items.create(
       title="Safety Verification Test",
       view="test-cases"
   )
   
   client.links.create(
       source_id=clinical_req.id,
       target_id=verification.id,
       link_type="verified_by"
   )
   ```

### Risk Management

```python
# Link risks to mitigations
risk = client.items.create(
    title="Risk: Device Malfunction",
    view="requirements",
    metadata={"severity": "high", "probability": "medium"}
)

mitigation = client.items.create(
    title="Mitigation: Redundant Safety Systems",
    view="requirements"
)

client.links.create(
    source_id=risk.id,
    target_id=mitigation.id,
    link_type="mitigated_by"
)
```

## Audit Trails

### Maintain Audit History

```python
# All changes are automatically tracked
# Export audit trail
audit_trail = client.export.audit_trail(
    project_id=project_id,
    item_id=item_id
)
```

## Related Documentation

- [Regulatory Compliance](./03a-regulatory-compliance) - Compliance workflows
- [Medical Devices](./03b-medical-devices) - Medical device development
