Software Verification Training for Medical Devices by Tonex
This comprehensive Software Verification Training for Medical Devices, presented by Tonex, equips professionals with critical skills for ensuring software safety and reliability in medical technology. It delves into rigorous verification methodologies, regulatory compliance, and best practices for developing secure medical software. This training significantly impacts cybersecurity by fostering robust testing and validation, mitigating vulnerabilities that could compromise patient safety and data integrity. It empowers participants to build resilient systems against evolving cyber threats.
Audience:
- Software Engineers
- Quality Assurance Professionals
- Regulatory Compliance Officers
- Medical Device Developers
- Cybersecurity Professionals
Learning Objectives:
- Understand software verification principles.
- Apply verification techniques to medical devices.
- Interpret relevant regulatory standards.
- Implement effective testing strategies.
- Identify and mitigate software vulnerabilities.
- Ensure compliance with cybersecurity requirements.
Course Modules:
Module 1: Foundations of Software Verification
- Introduction to Software Verification
- Verification and Validation Concepts
- Software Development Life Cycle Integration
- Risk Management Principles
- Verification Planning and Documentation
- Quality Assurance Best Practices
Module 2: Regulatory Compliance in Medical Devices
- FDA Regulations and Guidance
- ISO 13485 Standards
- IEC 62304 Compliance
- Data Integrity and Security
- Documentation Requirements
- Audit and Inspection Preparation
Module 3: Verification Techniques and Methodologies
- Static Analysis Techniques
- Dynamic Testing Strategies
- Unit Testing and Integration Testing
- System Testing and Validation
- Regression Testing Approaches
- Formal Verification Methods
Module 4: Cybersecurity in Medical Device Software
- Threat Modeling and Risk Assessment
- Vulnerability Analysis and Mitigation
- Secure Coding Practices
- Data Encryption and Access Control
- Incident Response Planning
- Cybersecurity Standards and Frameworks
Module 5: Test Case Development and Management
- Test Case Design Principles
- Test Data Management
- Test Automation Tools
- Test Execution and Reporting
- Defect Tracking and Resolution
- Test Coverage Analysis
Module 6: Advanced Verification and Validation Practices
- Usability Testing and Human Factors
- Performance and Stress Testing
- Verification of AI/ML-Based Devices
- Software Maintenance and Updates
- Post-Market Surveillance
- Continuous Improvement Strategies
Enroll today to enhance your software verification expertise and contribute to safer, more secure medical devices.