Medical Device Hazard analysis following ISO 14971

FDA expects risk management to be part of a medical device design control program and a post-production risk management program to be in place. It recommends ISO 14971 as a guide and accepts it as a recognized standard. Of the techniques ISO 14971 describes, hazard analysis is the most powerful, because it looks at risks in normal operation as well as in fault conditions, while FMEA and FTA look only at faults and work better as reliability tools.

This 60-minute medical device hazard analysis webinar explains the process in detail. It clarifies terms such as hazard, hazardous situation, harm, causative event, ALARP, risk index, benefit/risk ratio and residual risk, then works step by step through a risk analysis template with examples.

You'll also see how to handle residual risk, bring human factors studies into the analysis, connect hazard analysis to the design program, and apply ISO 14971 principles to software risk management.

• Explain hazard analysis terms such as hazard, hazardous situation, harm and risk
• Follow the hazard analysis process using a template
• Recognize examples of each key term
• Work through hazard analysis examples step by step
• Handle residual risk and link risk level to CAPA and validation effort
• Apply ISO 14971 principles to software risk management

• FDA expectations for design control and post-production risk management
• ISO 14971 as an FDA-recognized standard
• Why hazard analysis is more powerful than FMEA and FTA for product safety
• Key terms: hazard, hazardous situation, harm, causative event, ALARP, risk index, benefit/risk ratio and residual risk
• Step-by-step walk-through of a risk analysis template
• Examples of hazards and hazardous situations
• Dealing with residual risk
• Integrating human factors studies into hazard analysis
• Integrating hazard analysis into the design program
• Using risk level to set the extent of CAPA investigations and validation effort
• Applying ISO 14971 principles to software risk management

FDA expects risks to be analyzed and mitigated as far as practical during product development, and a risk analysis is required in an FDA product submission. Hazard analysis is the strongest risk tool in ISO 14971, but its many new concepts make it confusing.

This session explains those concepts with examples so the process is clear. It suits engineers, engineering managers, regulatory staff and QA professionals. Handouts include hazard analysis forms and a hazard analysis report template.

• Engineer
• Engineering Manager
• Regulatory Personnel
• QA

Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.