ISO 13485 + Risk Management (ISO 14971) Essentials Training by Tonex
Master the essentials of ISO 13485 and ISO 14971 with Tonex’s comprehensive training. This program delivers in-depth knowledge of quality management systems for medical devices. Understand regulatory requirements and risk assessment methodologies. Enhance your ability to navigate the complexities of medical device compliance. Crucial for cybersecurity, as it reinforces secure data handling and system integrity. This training strengthens defenses against vulnerabilities in interconnected medical systems. It ensures robust risk management, vital for safeguarding sensitive patient data.
Audience: Cybersecurity Professionals, Quality Managers, Regulatory Affairs Specialists, Medical Device Manufacturers, Engineers.
Learning Objectives:
- Understand the core requirements of ISO 13485.
- Apply ISO 14971 principles for risk management.
- Interpret regulatory expectations for medical devices.
- Implement effective quality management systems.
- Conduct thorough risk assessments.
- Ensure compliance with international standards.
Course Modules:
Module 1: Introduction to ISO 13485
- Overview of ISO 13485 standard.
- Quality management system requirements.
- Regulatory landscape for medical devices.
- Documentation and record control.
- Management responsibility and commitment.
- Resource management principles.
Module 2: ISO 13485: Process Approach
- Process identification and interaction.
- Process performance monitoring.
- Measurement, analysis, and improvement.
- Control of nonconforming product.
- Corrective and preventive action.
- Internal audits and management review.
Module 3: Introduction to ISO 14971
- Fundamentals of risk management.
- Risk management process overview.
- Terminology and definitions.
- Relationship between ISO 13485 and ISO 14971.
- Risk management planning.
- Risk analysis techniques.
Module 4: Risk Analysis and Evaluation
- Hazard identification methods.
- Risk estimation and evaluation.
- Risk acceptability criteria.
- Risk control measures.
- Residual risk evaluation.
- Risk management report.
Module 5: Risk Control and Production
- Implementation of risk control measures.
- Verification and validation of risk controls.
- Information for production and post-production.
- Risk management review.
- Monitoring post-market information.
- Maintaining risk management files.
Module 6: Compliance and Implementation
- Regulatory submissions and approvals.
- Implementation strategies for ISO 13485 and ISO 14971.
- Documentation requirements.
- Auditing and certification processes.
- Continuous improvement practices.
- Integration with existing systems.
Enroll today to enhance your expertise in medical device quality and risk management.