ComplianceOnline, Online Event
2013-08-16
Why Should You Attend: The number of FDA product recalls per year is currently is at all time high especially with devices containing embedded software. The FDA received more than 10,000 complaints per year on infusion pumps alone during this period. Some pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong data accidentally. However, FDA officials found that many deaths and injuries related to the devices were caused by product design and engineering flaws, rather than user errors. This webinar covers paradigms for proactive thinking and doing. It will show how to mitigate for user errors in the design of medical devices. Participants will learn to follow good evidence based design control, production validation, and accelerated test methodologies to prevent recalls. The presenter will highlight examples from his experience and use case studies to teach you strategies and interesting secrets that will be valuable in helping you prevent device recalls. Areas Covered in the Webinar: - Overview of FDA Quality System Regulation
- Overview of ISO 14971
- Writing good specification to avoid many sources of product flaws
- Design reviews for identifying potential recalls
- Tools for identifying sources of hazards
- Fault Tree Analysis to identify dangers in complex devices
- Identifying software hazards
- Developing a recall prevention program
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