6.5 Verification tests under MDR
This section of the technical documentation contains all verification tests performed to demonstrate that the medical device conforms to its design specifications. Each test has been conducted in accordance with the approved verification plan and documented with traceability to the corresponding design inputs.
Overview of verification strategy
Verification activities have been defined to cover all functional, safety, and regulatory requirements. Each test is linked to specific design inputs and acceptance criteria. Methods include physical testing, software validation, measurements, simulations, and inspections.
Structure of test documentation
For each verification test, the following elements are included:
- test name and objective
- reference to related design input
- test method and equipment used
- test protocol reference number
- test date and responsible person
- summary of results and compliance status
- conclusion and justification
Access to individual test reports
Each verification report is stored as a separate document with a unique identifier. The index of all test reports is provided below, including hyperlinks or references to their locations within the documentation system.
Index of verification test reports
- VT-001 functional test report
- VT-002 electrical safety verification
- VT-003 mechanical load testing
- VT-004 software verification summary
- VT-005 biocompatibility data integration
- VT-006 dimensional compliance check
- VT-007 packaging integrity test
- VT-008 transport simulation report
These reports collectively demonstrate compliance with the specified requirements and support the overall conformity of the medical device.
