Effective risk management requires analysis before the device is designed. This is essential for risk-based design input, and if it is not done early, then the risk information has little impact on the design. However, although it is required, the international standard for risk management (ISO 14971) gives very little guidance in this area.

This audio conference presentation shows how to accomplish risk-based design input early in the design process. It is intended for people who already have a basic understanding of risk management but are interested in ways to improve effectiveness in some of the more difficult and challenging areas of risk analysis.

This audio conference covers:

• Incorporating risk analysis early in the design process
• The difference between hazard and harm, and hazardous scenarios that may lead to harm
• Key methods to analyze designs for risk before the design is complete
• Utilizing the Fault Tree Analysis (FTA) method to systematically analyze risk
• Determining hazards prior to analysis
• Using team dynamics to define all practicable scenarios that lead to hazards

About the speaker:

Bernard Bosley PE is Risk Management Consultant with Koumu Engineering, Inc. and has specialized in risk management for medical devices and electro-mechanical reliability engineering since 2007. Previous to consulting he was responsible for risk management and standards compliance for the Neuromodulation business sector of Medtronic. He worked in this or similar capacity at Medtronic for 13 years, with experience covering several Medtronic business sectors such as Cardiac Rhythm Disease Management, Electrophysiology Systems, and Gastroenterology / Urology. Prior to Medtronic, he spent more than a decade in the aviation industry at Honeywell Commercial Avionics Systems and at Rosemount Inc. He is a licensed professional engineer in the state of Minnesota.

Who should attend?

Medical device industry professionals with experience in the following:

• Quality
• Reliability
• R&D Engineering
• Clinical
• Regulatory
• Product Safety
• Risk Management