Top-down Medical device vigilance involves taking into account information from the ANSM (French National Agency for the Safety of Medicines and Health Products) for:
- Linking it to a work order,
- Send it to the relevant department,
- Reject it, if the information does not concern any equipment.
Top-down medical device vigilance therefore works like a special work request.
Creating top-down biomedical device recall
- In the [Work] module, select the [Descendant biomedical device recall] function,
→ The list of descendant medical device vigilance reports is displayed.
- Click on the add icon
.
→ The create a descendant biomedical device recall form is displayed.
Processing top-down biomedical device recall
- See Taking Medical Device Monitoring into account.