IEC 62304 (Software Lifecycle for Medical Devices) Fundamentals Training by Tonex
This training provides a comprehensive understanding of IEC 62304, the international standard for medical device software lifecycle processes. Participants will learn regulatory requirements, risk management strategies, and best practices for software development. The course covers key compliance aspects, including verification, validation, and maintenance. It also explores classification, safety considerations, and documentation essentials. Designed for professionals in medical software development, this program ensures alignment with global standards. Gain insights into practical implementation and streamline compliance efforts.
Audience:
- Medical device software engineers
- Regulatory compliance professionals
- Quality assurance specialists
- Project managers in medical software
- Risk management professionals
- Medical software developers
Learning Objectives:
- Understand IEC 62304 requirements for medical device software
- Learn risk-based approaches to software development
- Ensure compliance with verification and validation processes
- Implement effective documentation and traceability practices
- Apply lifecycle models for medical software management
Course Modules:
Module 1: Introduction to IEC 62304
- Overview of IEC 62304 and its importance
- Scope and application in medical software
- Key terminology and definitions
- Relationship with other regulatory standards
- Classification of software safety classes
- Compliance challenges and industry adoption
Module 2: Software Development Processes
- Software development lifecycle models
- Key phases in medical software development
- Risk-based software design approaches
- Software requirement specification essentials
- Software architecture and design considerations
- Best practices for software implementation
Module 3: Software Risk Management
- Risk analysis and hazard identification
- Risk assessment methodologies in IEC 62304
- Risk control and mitigation strategies
- Integrating risk management into development
- Documentation of risk management activities
- Regulatory expectations for software safety
Module 4: Software Verification and Validation
- Importance of verification and validation
- Establishing test plans and procedures
- Unit, integration, and system testing approaches
- Traceability of requirements to test cases
- Handling test failures and corrective actions
- Compliance documentation for validation
Module 5: Software Maintenance and Configuration Management
- Software maintenance process requirements
- Change control and version management
- Impact analysis of software modifications
- Corrective and preventive action processes
- Documentation and record-keeping best practices
- Ensuring long-term software reliability
Module 6: Compliance and Documentation Essentials
- Essential IEC 62304 documentation requirements
- Preparing software development and maintenance records
- Audit preparation and compliance assessments
- Handling regulatory inspections and reviews
- Best practices for maintaining compliance
- Case studies on IEC 62304 implementation
Enhance your expertise in medical software compliance with this specialized training. Enroll now to master IEC 62304 fundamentals and improve your development processes!