Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.

This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.

This audio conference covers:

• An overview of ISO 14971 to place the presentation in context
• FDA requirements for risk analysis as part of design validation
• Recognition status of ISO 14971 by the FDA and for the EU MDD and IVDD
• The GHTF guidance document on risk management principles
• Developing a Risk Evaluation Matrix for your product
• Failure Modes and Effects Analysis (FMEA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Point (HACCP)

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Who should attend?

• Validation Professionals
• Design Engineers
• Project Managers involved in Design and Development
• Quality Engineers assigned to Validation activities
• Quality Auditors and Managers
• Quality staff assigned to Customer Complaints or CAPA Management