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Software Validation & Testing – Regulatory Requirements

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

Majority of the recent FDA recalls are software related. Perhaps most striking is the fact that one-third faced multiple recalls. It is a reminder that recalls can happen to any company—especially as more and more companies turn to complex software technologies. While most standards are helpful, they can be considered only minimum requirements where self-interest prevails. Even in healthcare where compliance to standards is at highest level, many patients die from errors in software designs, usually blamed on user errors. Understanding how mishaps can happen before they happen and preventing them by design is the key. Validation and testing for safety and reliability helps in achieving the ultra high software trustworthiness.

Course Objective:

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 reliable and safe performance is critical for efficient business strategy.

Course Outline:

• Regulatory requirements on  software risk management
• Paradigms for efficiency and cost reduction
• Identifying unknown risks
• Design control is the key to good software requirements
• Developing design control plan
• Negative requirement analysis for identifying trustworthiness  issues
• Definitions of defect, fault , malfunction, and trustworthiness
• Software reliability design considerations
• Principles of software design for trustworthiness
• Developing software verification plan
• Principles of software validation
• Developing  validation plan
• Testing for reliability
• Testing for 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
• Entire software engineering staff
• All hardware engineers
• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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