Testing and Validation Training for Medical Software by Tonex
Medical software requires rigorous testing and validation to ensure compliance, safety, and reliability. This training provides a structured approach to verifying software performance in healthcare environments. Participants learn best practices for regulatory compliance, risk assessment, and quality assurance. The course covers key validation techniques, software lifecycle testing, and documentation requirements. Through real-world case studies, professionals gain insights into testing challenges and solutions. The program equips attendees with the knowledge to enhance medical software reliability, mitigate risks, and meet industry standards.
Audience:
- Medical device software engineers
- Quality assurance professionals
- Regulatory compliance specialists
- Healthcare IT professionals
- Software developers in the medical field
- Validation and verification engineers
Learning Objectives:
- Understand medical software testing principles
- Learn regulatory requirements for validation
- Apply risk-based testing strategies
- Improve software quality and compliance
- Develop effective validation documentation
Course Modules:
Module 1: Introduction to Medical Software Testing
- Importance of software testing in healthcare
- Regulatory framework and industry standards
- Software validation vs. verification
- Risk classification in medical software
- Common challenges in medical software testing
- Best practices for ensuring software reliability
Module 2: Regulatory Requirements and Compliance
- Overview of FDA, ISO, and IEC standards
- Validation requirements for medical software
- Documentation and audit preparation
- Ensuring traceability in software testing
- Addressing compliance challenges
- Updates and trends in medical software regulations
Module 3: Software Testing Methodologies
- Black-box and white-box testing techniques
- Functional vs. non-functional testing
- Unit, integration, system, and acceptance testing
- Risk-based testing approaches
- Automation in medical software testing
- Developing effective test cases
Module 4: Risk Management in Software Validation
- Identifying and assessing software risks
- Implementing risk control measures
- Software failure modes and their impact
- Hazard analysis and mitigation strategies
- Compliance with ISO 14971 risk management
- Ensuring patient safety in software design
Module 5: Validation Documentation and Reporting
- Creating a validation master plan
- Writing detailed test protocols and reports
- Traceability matrix for software validation
- Handling validation deviations and failures
- Best practices for documentation compliance
- Preparing for regulatory inspections
Module 6: Case Studies and Industry Best Practices
- Real-world medical software validation examples
- Lessons learned from validation failures
- Improving software development lifecycle testing
- Effective communication in validation processes
- Addressing validation challenges in emerging technologies
- Future trends in medical software testing and validation
Enhance your expertise in medical software testing and validation with Tonex. Gain critical skills to ensure compliance, reduce risks, and improve software quality. Enroll today to stay ahead in the evolving healthcare industry!