Risk Assessment for Medical Devices

Medical devices must be safe and perform as designed. Risk or hazard analysis is the process that identifies what could make a device unsafe or stop it working as intended. This 60-minute medical device risk assessment webinar covers both the regulatory requirements and how to carry out the analysis.

21 CFR Part 820 calls for risk analysis as part of regulatory submissions and across the product lifecycle. ISO 14971, the risk management standard for medical devices, helps manufacturers identify hazards, estimate and evaluate risks, and put in place and monitor risk controls.

You'll follow a logical process from risk identification through rating and mitigation, including the risk management plan and documentation, asking the right questions, and the evaluation tools FTA, FMEA and FMECA.

• Explain why risk and hazard analysis is required for medical devices
• Describe the FDA and ISO 14971 requirements for risk management
• Build a risk management plan and supporting documentation
• Use fault tree analysis, FMEA and FMECA to identify and rate risks
• Select and monitor risk control and mitigation measures

• Why risk and hazard analysis matters
• Risk assessment defined
• Regulatory requirements: 21 CFR Part 820 and ISO 14971
• The risk management process and the risk management plan
• Risk management documentation
• Risk analysis processes and techniques
• Asking the right questions
• Evaluation tools: fault tree analysis (FTA), FMEA and FMECA
• Risk control and mitigation

Sound risk and hazard analysis is the best way to prevent medical device recalls or limit their impact. It is required by FDA and is central to developing devices that protect patients and manufacturers alike.

This session covers the basic principles of risk management and planning for device design and suits medical device manufacturers and anyone involved in making devices in a regulated environment.

• Anyone involved in the manufacturer of medical devices has had some exposure to the subject area and regulated environments.
• American Society for Quality
• Medical Device Manufacturers Association
• European Medical Device Technology
• Gulf Coast Medical Device Manufacturers
• Medical device manufacturers

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.