Introduction to ISO 14971:2019: Risk Management and Risk Analysis for Medical Devices Training by Tonex
This comprehensive course, “Introduction to ISO 14971:2019: Risk Management and Risk Analysis for Medical Devices,” offered by Tonex, is designed to provide participants with a deep understanding of ISO 14971:2019 standards and their application in the field of medical device risk management. Participants will gain insights into risk analysis methodologies, regulatory compliance, and best practices for effective risk management in the medical device industry.
Tonex offers a cutting-edge training program, “Introduction to ISO 14971:2019: Risk Management and Risk Analysis for Medical Devices.” This comprehensive course delves into the critical aspects of ISO 14971:2019, providing participants with a profound understanding of risk management and analysis in the context of medical devices.
Explore the purpose, scope, and evolution of the ISO standard, coupled with real-world case studies. Gain insights into key principles, risk analysis methodologies, and regulatory compliance. Taught by industry experts, this training equips professionals with the knowledge and skills to navigate the complexities of risk management, ensuring compliance and excellence in the dynamic field of medical devices.
Learning Objectives:
- Understand the key principles and requirements of ISO 14971:2019.
- Learn how to conduct risk analysis and assess the potential risks associated with medical devices.
- Gain insights into integrating risk management into the product development lifecycle.
- Acquire knowledge of regulatory compliance and documentation requirements.
- Develop skills to create and maintain a risk management file.
- Enhance decision-making capabilities by effectively managing and mitigating risks in medical device projects.
Audience: This course is tailored for professionals involved in the medical device industry, including product managers, quality assurance professionals, regulatory affairs specialists, design engineers, and anyone seeking a comprehensive understanding of ISO 14971:2019 and its practical application in risk management.
Course Outline:
Module 1: Introduction to ISO 14971:2019
- Purpose and Scope of ISO 14971:2019
- Evolution of the Standard
- Importance in the Medical Device Industry
- Overview of Risk Management Concepts
- Relationship with Other Regulatory Standards
- Case Studies and Practical Applications
Module 2: Key Principles of Risk Management
- Risk Acceptability Criteria
- Risk Management Process Overview
- Identification of Hazards and Potential Harm
- Risk Evaluation and Prioritization
- Risk Control Measures
- Residual Risk and Benefit-Risk Analysis
Module 3: Risk Analysis Methodologies
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Preliminary Hazard Analysis (PHA)
- SWOT Analysis in the Context of Risk Management
- Use of Risk Matrices
Module 4: Regulatory Compliance
- Overview of Global Regulatory Landscape
- FDA and CE Marking Requirements
- ISO 13485:2016 and its Relationship with ISO 14971
- Post-Market Surveillance and Reporting
- Auditing and Inspection Considerations
- Documentation for Regulatory Submissions
Module 5: Integration into Product Development
- Embedding Risk Management in Design Control
- Cross-Functional Collaboration in Risk Management
- Incorporating Risk Management in Verification and Validation
- Design and Process FMEA
- Updating Risk Management throughout the Product Lifecycle
- Case Studies on Successful Integration
Module 6: Documentation and Risk Management File
- Essential Components of a Risk Management File
- Documenting Risk Management Activities
- Traceability and Documentation Integrity
- Periodic Review and Updating of Risk Documentation
- Communication of Risks within the Organization
- Best Practices in Documenting Risk Mitigation Strategies