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
Shocking news about failures of medical devices. The FDA recalled more devices in the first quarter of 2018 than the entire year 2017!
Reliability has become a worldwide goal regardless of the industry. The engineering managers are intent on harvesting the value proposition for competing globally while significantly lowering the life cycle costs. The reliability fundamentals are based on proactively preventing hardware failures, software failures, and product malfunctions. Most experienced engineers are expert in a segment of the field, but urgently need to understand the entire science of reliability. This is obvious from the continuously increasing number of medical device recalls by the FDA for over the last 20 years.
This webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.
Course Objectives:
• Failure prevention
• Design requirements analysis
• Designing right the first time
• Software reliability
• Manufacturing reliability
• Life cycle costs reduction
• Design for trustworthiness
• Product durability
Why Should You Attend:
An average of three medical devices recalls taking place every day! This is too hazardous for the millions of patients. It is too costly for manufacturers of the devices. The science of reliability engineering requires creativity and innovative skills to aim at zero failures and elegant solutions that produce a high return on investment. Reliability is the final proof of efficiency and efficacy of a product. During this training, you will discover why statistical reliability predictions rarely correlate with field performance, how to make big reductions in warranty costs, how to eliminate failures during early design, how to select proper tests for production screening, how to set up accelerated life tests, how to manage reliability growth, and how to predict the product life.
Course Outline:
• The new paradigms for designing for reliability
• How to write good engineering specifications
• How to write manufacturing specifications for defect free production
• How to use failure prevention tools
• Failure mode, effects, and criticality analysis
• Develop design and manufacturing reliability validation tests
• How to use creativity for design solutions that cost very little or nothing
• Case histories of zero failures at low costs
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Engineering managers
• R&D engineers
• Design engineers
• Reliability Engineering staff
• Manufacturing Engineering staff
• Quality Assurance staff
• Regulatory Affairs staff
• Marketing managers
• Maintenance engineering managers
Risk Assessment in Medical Device Design
LIVE : Scheduled on
08-January-2025 :01:00 PM EST
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The DHF, DMR, DHR, and Technical Documents File
LIVE : Scheduled on
09-January-2025 :01:00 PM EST
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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
LIVE : Scheduled on
16-January-2025 :01:00 PM EST
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