Define comprehensive software testing approach verifying requirements and ensuring regulatory compliance.
Test ID | Requirement | Test Description | Acceptance Criteria |
---|---|---|---|
TC-001 | REQ-001 | Manual glucose entry validation | App accepts valid glucose values (20-600 mg/dL), rejects invalid values with clear error message |
TC-002 | REQ-005 | Insulin calculation accuracy | Calculated insulin dose within ±5% of expected value for standard clinical scenarios |
TC-003 | REQ-012 | Bluetooth device pairing | App successfully pairs with supported glucose meters within 30 seconds |
TC-004 | REQ-018 | Extreme value warnings | App displays appropriate warnings for glucose <70 or >300 mg/dL |
How should software testing be documented for regulatory compliance?
What level of test automation is expected for medical device software?
How should Software of Unknown Provenance (SOUP) be addressed in system testing?
What should be done when test cases fail during execution?
How should cybersecurity testing be integrated into software system testing?
What is the relationship between software system testing and usability testing?