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Software Validation & Testing - Regulatory Requirements

Wednesday, 06 June 2018  11:30 AM PDT, 02:30 PM EDT

Training Duration = 90 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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 occur and preventing them by design is the key. Validation and testing for safety and reliability helps in achieving the ultra high software trustworthiness.

Learning Objectives:

  • 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

Why Should You Attend:

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.


Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical de

Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management and the online faculty at University of Maryland where he teaches courses on Reliability.

He is a Founding Fellow of American College of Healthcare Trustees and a member of American College of Healthcare Executives, He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners.

He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital. He helped them in providing 24/7 access to family members of patients and reduced the number of alarms for nurses so they recognize critical patient needs early.