Handling complaints about medical devices (GUI-0065): References
Legislation
Guidance documents
- Guidance document – Private label medical devices
- Draft guidance on how to interpret 'significant change' of a medical device
- Guide for recalling medical devices (GUI-0054)
- Incident reporting for medical devices: Guidance Document
- Foreign risk notification for medical devices guidance document
- Guidance on summary reports and issue-related analyses for medical devices: Summary reports