Create specialized testing strategies addressing cybersecurity, performance, and integration requirements.
Test Category | Test Description | Acceptance Criteria |
---|---|---|
Authentication Testing | Verify user authentication mechanisms | Multi-factor authentication required, session timeout <30 minutes |
Data Encryption | Validate encryption of sensitive data | AES-256 encryption for data at rest, TLS 1.3 for data in transit |
API Security | Test API authentication and authorization | All API calls require valid authentication tokens |
Penetration Testing | Simulate attack scenarios | No critical vulnerabilities identified |
Input Validation | Test handling of malicious inputs | All inputs properly validated and sanitized |
Validation Component | Method | Acceptance Criteria |
---|---|---|
Prediction Accuracy | Retrospective analysis with clinical datasets | Mean absolute error <15 mg/dL for 4-hour predictions |
Dosing Safety | Clinical expert review of recommendations | No unsafe dosing recommendations in test scenarios |
Population Diversity | Subgroup analysis by age, diabetes type | Algorithm performance consistent across subgroups |
Edge Case Handling | Testing with extreme glucose values | Appropriate warnings for values outside normal range |
Performance Metric | Requirement | Test Method |
---|---|---|
App Response Time | <2 seconds for all user actions | Automated UI testing with timing measurements |
Data Sync Time | <30 seconds for glucose reading upload | Network simulation testing |
Concurrent Users | Support 10,000 simultaneous users | Load testing with simulated user sessions |
Battery Impact | <5% battery drain per hour of active use | Power consumption measurement |
Integration Point | Test Scenario | Acceptance Criteria |
---|---|---|
Bluetooth Pairing | Device discovery and pairing | Successful pairing within 30 seconds |
Data Transfer | Glucose reading transmission | 100% data integrity during transfer |
Cloud Sync | Data backup and retrieval | Successful sync with <1% data loss |
Offline Mode | App functionality without connectivity | Core features available offline |
Error Recovery | Handling of connection failures | Graceful error handling with user notification |
How do I determine if I need additional software test plans beyond system testing?
What level of cybersecurity testing is required for medical device software?
How should I validate artificial intelligence or machine learning algorithms?
Can additional test plans be combined or should they be separate documents?
How do I coordinate additional test plans with overall V&V activities?
What should I do if additional testing reveals issues not found in system testing?