Index a medical-device event against the sponsor and facility reporting paths
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- From the incident note, list the device, the date of use, the facility, whether a sponsor has already reported, and which of the minimum fields are missing. Do not lodge a report.
- What the lawyer must review
- The lawyer decides whether the facility or the sponsor must report, and lodges any report.
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | Consider narrowly defined preparation support after confirming the tool’s capability and permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.