Medical Device Risk Management Workshop by Tonex
This workshop provides a comprehensive understanding of risk management in medical device development. Participants will learn about regulatory frameworks, risk assessment techniques, and compliance requirements. The course covers risk identification, evaluation, mitigation, and monitoring strategies to enhance patient safety. Attendees will explore industry standards, including ISO 14971, and gain insights into best practices for integrating risk management into the product lifecycle. The program is designed for professionals involved in medical device design, manufacturing, and compliance. By the end of the workshop, participants will have the knowledge to implement effective risk management strategies in their organizations.
Audience:
- Medical device engineers
- Quality assurance professionals
- Regulatory affairs specialists
- Risk management professionals
- Product development teams
- Compliance officers
Learning Objectives:
- Understand the fundamentals of medical device risk management
- Learn regulatory requirements and industry standards
- Apply risk assessment and mitigation techniques
- Develop effective risk management plans
- Ensure compliance throughout the product lifecycle
Course Modules:
Module 1: Introduction to Medical Device Risk Management
- Overview of risk management principles
- Importance of risk management in medical devices
- Regulatory landscape and compliance requirements
- Key stakeholders and responsibilities
- Integrating risk management into product development
- Case studies on medical device failures
Module 2: Regulatory Standards and Compliance
- Understanding ISO 14971 requirements
- FDA regulations and global standards
- Documentation and reporting guidelines
- Risk management in pre-market and post-market phases
- Best practices for regulatory compliance
- Common pitfalls in regulatory adherence
Module 3: Risk Identification and Assessment
- Hazard identification techniques
- Risk analysis methodologies
- Severity and probability assessment
- Failure mode and effects analysis (FMEA)
- Hazard analysis and critical control points (HACCP)
- Using data for risk assessment
Module 4: Risk Mitigation and Control Strategies
- Developing risk control measures
- Implementing design controls for risk reduction
- Verifying and validating risk controls
- Risk-benefit analysis for decision-making
- Monitoring residual risks in medical devices
- Post-market surveillance strategies
Module 5: Risk Communication and Documentation
- Importance of effective risk communication
- Preparing risk management files and reports
- Communicating risks to stakeholders
- Training teams on risk management procedures
- Aligning documentation with compliance requirements
- Case studies on risk communication failures
Module 6: Continuous Risk Management and Improvement
- Monitoring and reviewing risk management effectiveness
- Implementing corrective and preventive actions
- Lessons learned from past medical device recalls
- Enhancing risk culture within organizations
- Integrating risk management with quality management systems
- Future trends in medical device risk management
Enhance your expertise in medical device risk management. Join Tonex’s workshop to gain practical insights, ensure compliance, and improve patient safety. Register today!