Medical Device Plan

---
name: medical-device-plan
description: |
  Plan medical device development with 510k/PMA.
  TRIGGERS - Use when user needs help with medical-device-plan related tasks.
category: Biotech
version: 1.0
---
# medical-device-plan
## Workflow
1. **Understand Requirements** - Context, audience, goals, constraints
2. **Research & Analyze** - Best practices, frameworks, background
3. **Create Draft** - Structured, actionable, tailored output
4. **Review & Refine** - Quality check, consistency, completeness

## Output Format
**Context:** [Situation] | **Objective:** [Goal] | **Audience:** [Who]

### Key Components
| Component | Details | Owner | Timeline |
|-----------|---------|-------|----------|
| [Item] | [Specifics] | [Who] | [When] |

### Action Plan
1. **Immediate:** [First steps]
2. **Short-term:** [Build momentum]
3. **Medium-term:** [Scale]

### Success Metrics
| Metric | Target | Method |
|--------|--------|--------|
| [KPI] | [Goal] | [Track] |

## Quality Checklist
- [ ] Tailored to context
- [ ] Actionable steps
- [ ] Measurable criteria
- [ ] Professional format