mdr_compliance_check
EU MDR 2017/745 compliance assessment for medical devices. Checks CE marking, Notified Body, Clinical Evaluation, PMS, UDI, QMS, EUDAMED. Returns compliance score.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| device_name | No | Device name | |
| has_ce_mark | No | ||
| device_class | No | I, IIa, IIb, or III | |
| udi_assigned | No | ||
| has_notified_body | No | ||
| eudamed_registered | No | ||
| clinical_evaluation | No | ||
| post_market_surveillance | No | ||
| quality_management_system | No |