Device Info (Step 1)
Step 1 confirms the device's intended purpose, indications, and target population. This information underpins all subsequent steps.
Workflow
- Auto-generate: AI generates intended purpose based on project info and context files
- Review: Check accuracy and completeness
- Edit: Make corrections if needed
- Approve: Confirm to proceed
Generated Content
- Device name and classification
- Intended purpose description
- Indications and contraindications
- Target patient population
- Intended users
- Use environment and conditions
- Mechanism of action
- Expected clinical benefits