Software FMEA for Medical Devices

Duration: 60 Minutes
Software related device recalls are steadily going up for the last 10 years. The biggest reason is that missing and vague requirements in software specifications are responsible for at least 50% failures. Therefore risks are inherent in software design and development, even after so much attention paid to the design control process. You can identify more risks than you know if you use the Software Failure Mode and Effects Analysis (FMEA). This tool predicts many life cycle failures; assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.
Medical Devices- Risk Management
Instructor: Dev Raheja
Product ID: 501324
Objectives of the Presentation
  • ISO 14971 requirements for FMEA
  • Difference between software FMEA and hardware FMEA
  • How can we apply FMEA to software design?
  • FMEA at several levels of software
  • Predicting software malfunctions and failures
  • Applying risk acceptance criteria
  • Failure avoidance strategies
  • FDA requirements for software design control
  • Role of management in software design
Why should you Attend
Understanding system failures in advance and evidence based best software practices is a profound knowledge. This webinar is conducted by the international risk management consultant with over 30 years experience and the author of the text Preventing Medical Device Recalls.

Areas Covered
  • Software FMEA fundamentals
  • Frequent mistakes in FMEA
  • Different levels for FMEA
  • System Functions FMEA
  • Subsystem level FMEA
  • Module level FMEA
  • Code level FMEA
  • Interface FMEA
  • Severity rating scale
  • Probability rating scale
  • Risk assessment
  • Risk mitigation
  • Software change control
  • Configuration accounting
  • Post control risk evaluation
  • Example of a good Software FMEA
  • Reporting the results of FMEA
  • Using FMEA as a living document
Who can Benefit
  • Senior Management
  • Software Development Managers and Engineers
  • Hardware Managers and Engineers
  • Quality Assurance Staff
  • Regulatory Affairs Staff
  • Service Engineering Managers and Engineers
Topic Background
Software is the most critical part of the medical devices. There is a potential for too many mistakes. Good FMEA starting with the performance specification can help very significantly. In addition, the FMEA should be done for the functions, modules, interfaces, and user interfaces.
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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 device, healthcare and aerospace industry for over 25 years. 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.
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