Find and Fix Defects Before Your Devices Go to Market Using FMEA to Design Defect-free Medical Devices
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The FDA estimates nearly 50 percent of all device recalls are attributed to poor product design.
And a major device recall can mean losses of billions of dollars to your company. Consider these examples:
- An implantable cardioverter-defibrillator lead — approved by the FDA despite having no human clinical data — was recalled after 268,000 implantations worldwide when its tendency to fracture was discovered
- A major medical device manufacturer recalled more than 50,000 pacemakers over a potential short-circuit
- Another manufacturer posted a $20 million bond to guarantee its infusion pumps would be brought into compliance with FDA cGMP requirements — and will spend an estimated $65 million in repairs
Design problems can be caught earlier — so your company can prevent warning letters, potential recalls, lawsuits and patient deaths.
Get a clear understanding of how to conduct a Failure Modes and Effects Analysis (FMEA) to reduce these risks. Angelo Scangas will explain the value of the FMEA process, walk you through a sample, completed FMEA spreadsheet and show you how to utilize FMEA to develop safe and effective medical devices.
Order now for your entire team to listen in and discover:
- The applicable FDA risk management regulations and guidance regarding design controls
- The applicable ISO risk management standards regarding design controls
- Definitions of "harm", "hazard" and "risk"
- The 4 types of Failure Mode and Effects Analysis (FMEA), and their respective objectives
- Design
- Product
- System
- Process
- The top 10 implementation strategies for effective FMEA
- When is the best time within the design process to conduct a FMEA
- Choosing the best leader of a FMEA project and what departments should be included on the team
- How to identify the correct criteria for the inclusion of severity, occurrence and detection data points
- The 5 most common potential failure modes when preparing an FMEA
- Strategies for identifying causes and effects for each failure mode
- How to develop "risk priority numbers" and prioritize problems for CAPA
Understand how to conduct a FMEA to reduce risks of design problems.