Introduction to ISO 14971: Risk Management of Medical Device Software Training by Tonex
This comprehensive training course, “Introduction to ISO 14971: Risk Management of Medical Device Software” by Tonex, is designed to provide participants with a deep understanding of ISO 14971 and its application to the risk management of medical device software. The course delves into the key principles, processes, and methodologies essential for ensuring the safety and effectiveness of medical device software throughout its lifecycle.
Tonex presents the “Introduction to ISO 14971: Risk Management of Medical Device Software” training, offering a dynamic learning experience for professionals in the medical device industry. This course provides a comprehensive understanding of ISO 14971, focusing on its crucial application to the risk management of medical device software.
Participants will delve into key principles, regulatory compliance, and best practices. By the course’s end, attendees will possess the skills to identify, assess, and manage risks associated with medical device software, ensuring compliance with industry standards. Join us for a transformative learning journey that equips you with the knowledge needed to enhance the safety and efficacy of medical device software.
Learning Objectives:
- Gain a thorough understanding of ISO 14971 and its relevance to medical device software.
- Learn how to identify, assess, and prioritize risks associated with medical device software.
- Acquire skills in implementing risk management processes in compliance with ISO 14971.
- Understand the documentation requirements for risk management in medical device software development.
- Explore best practices for mitigating and controlling risks throughout the software lifecycle.
- Prepare for successful integration of ISO 14971 principles into your organization’s quality management system.
Audience: This course is tailored for professionals involved in the development, testing, and quality management of medical device software, including engineers, project managers, regulatory affairs specialists, and quality assurance professionals. It is also suitable for individuals seeking a comprehensive overview of ISO 14971 in the context of medical device software.
Course Outline:
Module 1: Introduction to ISO 14971
- Overview of ISO 14971
- Significance in the Medical Device Industry
- Key Principles of ISO 14971
- Regulatory Landscape and Compliance
- Integration with Quality Management Systems
- Importance in Ensuring Patient Safety
Module 2: Fundamentals of Medical Device Software Risk Management
- Basics of Risk Management
- Risk Identification in Software Development
- Risk Assessment Techniques
- Risk Prioritization Methods
- Relationship Between Software and Device Risks
- Impact of Software on Overall Device Safety
Module 3: ISO 14971 Risk Management Process
- Detailed Analysis of ISO 14971 Processes
- Hazard Analysis and Risk Evaluation
- Risk Control Measures
- Residual Risk Assessment
- Risk Management Plan Development
- Continuous Improvement in the Risk Management Process
Module 4: Risk Identification and Assessment for Medical Device Software
- Identifying Software-specific Risks
- Analyzing Potential Consequences
- Probability and Severity Assessment
- Human Factors in Risk Identification
- Use of Tools and Templates
- Case Studies on Effective Risk Identification
Module 5: Documentation Requirements
- Essential Documentation in ISO 14971
- Risk Management File Components
- Traceability Matrix
- Documenting Risk Control Measures
- Records Maintenance
- Compliance with Regulatory Documentation Standards
Module 6: Best Practices and Case Studies
- Implementing ISO 14971 Best Practices
- Industry Standards and Guidelines
- Role of Risk Management in Software Development Lifecycle
- Case Studies on Successful Risk Mitigation
- Lessons Learned from Notable Failures
- Continuous Improvement Strategies for Risk Management