Documentation Templates
Ready-to-use forms and templates for MDR/IVDR compliance activities
Note: These templates are provided as starting points. Adapt them to your organization's specific needs and ensure they comply with your national requirements and internal policies.
Device Acceptance Record
Document new device receipt and acceptance testing
Medical Device Incident Report Form
Document device-related incidents for internal and external reporting
FSCA Tracking Form
Track Field Safety Corrective Actions from receipt to completion
Medical Device Register Template
Master record template for device inventory tracking
Device Training Record
Document user training on medical devices