Software Development Life Cycle (SDLC) Testing
- Traceability Analysis
Ensures all software requirements are mapped to design, implementation, and verification artifacts (as required by IEC 62304).
- Unit Testing
Verifies functionality of individual software modules using automated tools or test scripts.
- Integration Testing
Assesses interfaces and data flow between combined software components.
- System Testing
Tests the fully integrated system to validate that it meets user and functional requirements.
- Regression Testing
Ensures new updates or patches haven’t introduced unintended changes or defects.
Verification & Validation (V&V)
- Static Code Analysis
Analyzes source code without executing it—detects bugs, security vulnerabilities, memory leaks, etc.
- Dynamic Code Analysis
Tests code during execution to identify run-time errors, resource leaks, and unsafe operations.
- Code Coverage Analysis
Determines the percentage of code exercised during testing (statement, branch, path coverage).
- Boundary and Equivalence Partitioning Tests
Validates input field handling and ensures proper behavior for edge cases.
- Failure Mode and Effects Analysis (FMEA)
Identifies and prioritizes failure risks within software logic or modules.
- Real-Time Performance Testing
For systems that rely on timing (e.g., infusion pumps, ventilators), ensuring deadlines are met.
Mobile App / Connected Software Testing
- Device pairing and communication validation (e.g., Bluetooth, NFC)
- Cross-platform compatibility (iOS/Android)
- Cloud connectivity and API response testing
- Offline/online synchronization validation
- Data persistence and recovery testing
- App store deployment compliance
Cybersecurity Testing for Medical Devices
Risk-Based Cybersecurity Assessments
- Threat Modeling / Attack Surface Analysis
Identifies potential entry points and paths for cyber-attacks.
- Vulnerability Scanning
Uses automated tools to identify known vulnerabilities in software libraries, OS, or configurations.
- Penetration Testing (Pen Testing)
Simulated attacks on the device or software to uncover exploitable weaknesses.
- Secure Boot & Firmware Validation
Ensures the device only runs trusted, signed firmware.
- Authentication & Authorization Testing
Verifies proper enforcement of user roles, permissions, and credential protection.
- Data Encryption Validation
Confirms that data at rest and in transit are encrypted using industry standards (e.g., AES, TLS).
- Session Management Testing
Checks token expiration, session hijacking resistance, and logout behavior.
- Audit Trail and Logging Testing
Validates integrity, timestamping, and accessibility of logs for regulatory compliance (e.g., FDA Part 11).
- Wireless Coexistence Testing
Ensures the device performs correctly in environments with competing wireless signals.
- Denial of Service (DoS) Simulation
Assesses how the system reacts to resource exhaustion attacks (e.g., overloads, floods).
Compliance and Documentation Support
- SBOM (Software Bill of Materials) Analysis
Lists all open-source and third-party software used, along with associated vulnerabilities.
- Cybersecurity Risk Management Report
Documents risk controls and residual risks based on ISO 14971 and FDA expectations.
- IEC 81001-5-1 Compliance Assessment
Evaluates adherence to new software cybersecurity lifecycle process standard for health software.
- FDA Premarket Cybersecurity Requirements
Support for meeting expectations in FDA guidance (October 2023 update), including “reasonable assurance” of safety and effectiveness from a cybersecurity perspective.
- IMDRF Cybersecurity Framework Mapping
Aligns with international expectations for pre- and post-market cybersecurity controls.