Designing Medical Devices for Safety, Reliability, and Maintainability
Duration : 75 Minutes
Dev Raheja,
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologi Read more
The challenges faced by medical device manufacturers in bringing safe, reliable, low overall life-cycle cost devices to market in a timely manner is increasing rapidly. The increasing complexity and software criticality of medical devices is driving the need for a proactive practice of risk prevention. However, theoretical knowledge is not enough.
The number of FDA product recalls in the U.S. has been going up for the last 10 years. The FDA receives more than 10,000 complaints per year on infusion pumps alone. Some pump manufacturers say that most problems occur when a nurse or
Course Objectives:
The legal system, The FDA, and the European standards require the device to be safe as long as it is in use. Therefore high reliability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, safe customers, more loyal customers, and more sales.
The FDA reviews the results of the performance tests during pre-market approvals, and in complaint investigations. Therefore a thorough understanding of designing device for long, reliable and safe life by the entire staff is critical
Course Outline:
• The process for designing for reliability
• The process
• System Hazard Analysis
• The process for designing for maintainability
• Designing for Inherent Quality
• Designing to Forgive User Errors
• Design control
• Testing for reliability
• Testing for safety
• Production testing for validating reliability and safety
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management
• Design staff
• Manufacturing engineering staff
• Software engineering staff
• Regulatory affairs professionals
• Marketing Managers
• Service managers
• Project Managers and engineers
• Quality Assurance staff
• Regulatory staff
• IT professionals looking to make the design process efficient
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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