5 How to set up reporting rules
The recommended reporting rules that are needed when you enable eMDR report scheduling.
Country | License type | Agency | Rule Name | Time frame | Report Form | Condition |
---|---|---|---|---|---|---|
United States | Marketed Device | CDRH | 5-day | 5 | eMDR | A criteria that uses Advance conditions with
Remedial Action.
Any other condition as per your company’s business process. |
United States | Marketed Device | CDRH | 30-day | 30 | eMDR | Case Serious = NO
Criteria using Advance conditions with Malfunction = Yes Any other condition as per your company’s business process. |