Reliability of Medical Devices: Ensuring Availability and Safety
Note: This publication will be available in PDF format by Dec. 11, 2020.
If you don’t understand how the concept of reliability is defined, you’re not alone.
While FDA regulations use the term “reliability,” they don’t define the concept — making it important for devicemakers to develop their own objective, quantifiable methods for demonstrating product reliability. A proven reliability measure makes a device more attractive to buyers and is the basis for developing warranty terms.
Take your devices to the next level of reliability and achieve the best in product quality with the new management report Reliability of Medical Devices: Ensuring Availability and Safety.
There are a variety of statistical analysis tools that can help you rate the reliability of your products. Along with explaining the concept of reliability and how it relates to risk, this management report presents a process for analyzing reliability as well as several formulas and statistical graphing methods for arriving at a reliability measure. These methods include life distribution, hazard rate, the bathtub curve, failure mode analysis, criticality analysis, fault tree analysis and reliability block diagrams.
Reliability of Medical Devices will cover:
- Definitions of reliability, availability and maintainability
- How to compare quality and reliability over the device lifecycle
- Acceptable units of measure
- How to determine variability
- Methods for improving availability
- International standards for failure mode analysis, fault tree analysis and reliability block diagrams
Reliability is often not well understood, despite it being vital to devicemakers. Take your medical device to the next level with proven reliability tools and techniques. Order your copy today.
Who Will Benefit
- Quality Managers
- Quality Engineers
- Production Managers
- Manufacturing Engineers
- Production Engineers
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Dec. 11, 2020
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