Software FMEA for Medical Devices
Duration : 90 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
Software Issues Are the Leading Cause of Medical Device Recalls. On Average, the FDA Issues 1.5 Recalls Each Week.
Software risk analysis is more difficult than hardware analysis. Because of thousands of interactions within and with other devices. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and devices.
The disciplines of gathering such intelligence on interactions are often missing. This is one reason for increase in device recalls. Most manufacturers have not applied rigors of hardware risk analysis to software designs. The same methods apply to software even though there are differences in software and hardware. This webinar will cover the major risk prevention tool, the Software FMEA (Failure Mode and Effects Analysis)
Course Objectives:
• The need for a cost reduction is obvious, because a fault fixed during the concept stage costs only a l fraction compared to the warranty and recall costs
• The risk of the known, the risk of known unknowns, and the risk of unknown unknowns
• Software FMEA to of over 60% of the potentially missing requirements”
• Understanding complementary properties, capabilities from a system of systems
• Explain through examples the process of conducting the Software FMEA
Why Should You Attend:
The purpose of this webinar to eliminate very high risks from high number of missing requirements in the specifications making it impossible to predict risks. That is why the number of software related recalls are increasing every year in the last decade.
Course Outline:
• Software Requirements Analysis
• Software Failure Mode and Effects Analysis
• Software Inter-operability analysis
• Software Testability Analysis
• Selecting Software Structure and Architecture
• Precautions for off-the-shelf software
• Designing to Minimize User Interface Risks
• Software Development Standards and guidance documents
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
• Entire engineering staff
• All technical managers
• Test engineering staff
• Regulatory affairs professionals
• Marketing Managers
• Service managers
• Project Managers and engineers
• Quality Assurance staff
• IT professionals looking to make the design process efficient
• Presidents and CEO's
• Vice Presidents
• R&D managers and engineers
• Design engineers
• Test engineers
• Quality Assurance Managers / Administration
• Risk Managers
• Safety staff
• Maintenance staff
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
