Program Summary:

Risk Management is an essential topic for a Medical Device. It provides a framework for the systematic evaluation of what can go wrong with your device. It also looks at the potential impacts to patients and caregivers if a failure has occurred. The international standard for Risk Management: ISO 14971 is recognized by the FDA as the best practice for assessing and documenting hazards and impacts for a Medical Device. The seminar will provide an overview of these methods and the process to create a Risk Management File that will meet the Regulatory requirements pertaining to Risk Management.

Key Takeaways:

Goals of Risk Management

• Identify the Hazards in using the product
• Estimate and Evaluate Risks Resulting from the Hazards
• Develop the Product with Risk Reduction in Mind
• Implement Controls to Reduce Risk
• Implement Tools to Evaluate and Measure Risk Controls

Risk Management Activities & Deliverables

• Planning => Risk Management Plan
• Doing => Risk Management Report
• Risk management impacts other activities

Presenter: Greg Schultz

Greg Schultz has 30 years of product development experience, almost entirely in the medical field. He has extensive experience developing software ranging from real-time embedded systems to Windows-based applications. Greg has experience developing software used in both Class II and Class III medical devices, complying with the IEC 62304 Software Life Cycle Processes standard for both new and legacy devices. Prior to co-founding Design Solutions, Greg held lead software engineering and management positions at Angeion, Medtronic, Beckman Coulter, CNS Inc. and ACIST Medical Systems. Greg has a BSEE degree from the University of North Dakota and an MBA from the University of St. Thomas.

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