Reliability for Medical Devices – Webinar Recording/Transcript
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Take your medical devices to the next level of reliability with this presentation. Dan O’Leary, President of Ombu Enterprises, will use examples to explain how to implement the tools and methods you need to provide the most reliable devices.
He’ll show you how to distinguish between reliability and safety, so you can home in on improving reliability. While there’s much overlap, they require different tools and techniques for analysis.
You’ll also be able to distinguish between the reliability of hardware and software — both can affect reliability but use different analytical approaches.
The tools and techniques Dan will use include failure mode effects and criticality analysis (FMECA), which analyzes a single-point failure and its effect on the device; fault tree analysis (FTA), which determines combinations of events that contribute to a device failure; reliability prediction, which estimates the reliability of a device during development; reliability block diagram (RBD), which determines the structure of a device and the contributions to reliability; and failure reporting, analysis and corrective action system (FRACAS), to report failures and take corrective action.
- An introduction to the concepts of reliability
- An introduction to the concepts of maintainability
- Availability as the combination of reliability and maintainability
- Distinguishing between safety and reliability
- Methods and tools for reliability
- The relationship between reliability and warranty cost (early failures in particular can significantly affect warranty claims)
Reliability is often not well understood, despite it being vital to devicemakers. Bring your products to the next level by implementing these tools and techniques.
Meet Your Presenter
Dan O’Leary is the 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’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Master’s Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit
People involved in the inspection, measuring and test equipment (IM&TE) control program, particularly:
- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
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Oct. 15, 2020