Introduction to IEC 62304 (Medical Device Software) Training by Tonex
This course provides a comprehensive introduction to IEC 62304, the international standard for medical device software lifecycle processes. Participants will learn key requirements, risk management integration, and compliance strategies. The training covers software development, maintenance, and documentation to meet regulatory expectations. Through expert guidance, attendees will gain insights into industry best practices for software safety and effectiveness. This course is essential for professionals involved in medical device software development and regulatory compliance.
Audience:
- Medical device software engineers
- Quality assurance professionals
- Regulatory affairs specialists
- Compliance officers
- Product managers
- Healthcare technology developers
Learning Objectives:
- Understand the structure and purpose of IEC 62304
- Learn software lifecycle processes and requirements
- Integrate risk management into software development
- Ensure regulatory compliance and documentation accuracy
- Apply industry best practices for software safety
Course Modules:
Module 1: Overview of IEC 62304
- Introduction to medical device software standards
- Scope and applicability of IEC 62304
- Key terms and definitions
- Relationship with other regulatory frameworks
- Importance of software safety classifications
- Compliance challenges and solutions
Module 2: Software Development Lifecycle Under IEC 62304
- Software development planning essentials
- Requirement management and traceability
- Design and implementation guidelines
- Software unit verification and integration
- Testing strategies for medical device software
- Configuration management best practices
Module 3: Software Risk Management and Safety Classification
- Principles of risk management in software development
- Risk classification levels and assessment
- Implementing risk control measures
- Integrating ISO 14971 into IEC 62304
- Software hazard analysis techniques
- Risk documentation and reporting
Module 4: Software Maintenance and Change Management
- Post-market software maintenance process
- Change impact assessment and validation
- Software update and patch management
- Incident and problem resolution strategies
- Documentation requirements for maintenance
- Compliance considerations for software changes
Module 5: Verification, Validation, and Testing Requirements
- Key concepts in verification and validation
- Static and dynamic testing methodologies
- Software integration and system testing
- Performance evaluation and acceptance criteria
- Validation documentation and traceability
- Common pitfalls in software verification
Module 6: Compliance and Regulatory Considerations
- Overview of global regulatory expectations
- FDA and EU MDR compliance requirements
- Auditing and inspection preparedness
- Software documentation and reporting
- Common compliance challenges and resolutions
- Best practices for regulatory success
Enhance your expertise in medical device software development with this in-depth IEC 62304 training. Stay ahead of regulatory changes and improve software compliance. Enroll today!