Risk Analysis in the Medical Device Design Process

A medical device has to be safe to use and do what it was designed to do. Risk analysis, also called hazard analysis, is the process that finds the risks that could make a device unsafe or stop it working as intended.

21 CFR Part 820 calls for thorough risk analysis as part of regulatory submissions and across the product lifecycle, and ISO 14971 is the risk management standard for medical devices. It helps manufacturers set up a process to identify hazards, estimate and evaluate risks, and put in place and monitor risk control measures.

This 90-minute medical device risk analysis webinar covers the regulatory requirements and a practical process for effective risk and hazard analysis during design.

• Explain why risk and hazard analysis matters in medical device design
• Define risk assessment and the related regulatory requirements
• Build a risk management plan and keep the required documentation
• Use risk analysis processes and ask the right questions
• Rate risks with FTA, FMEA and FMECA
• Choose and apply risk control and mitigation measures

• Why risk and hazard analysis is important
• Risk assessment defined
• Regulatory requirements under 21 CFR 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 and analysis tools: FTA, FMEA and FMECA
• Risk control and mitigation

Sound risk and hazard analysis is the key to preventing medical device recalls, or at least limiting their impact, and it protects patients and manufacturers alike. Beyond being required, it is central to developing safe devices.

The session explains the principles of risk management and planning that FDA expects in device design, a logical process from identification through rating and mitigation, and the FTA, FMEA and FMECA tools. It suits device and design engineers, scientists, regulatory associates, managers and directors.

• Medical Device Engineers
• Scientists
• Design Engineers,
• Regulatory Associates Etc.
• Managers,
• Associate Directors,
• Directors and Associates of all levels

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.