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.
Risk Management for Medical Devices
Instructor: Dev Raheja
Product ID: 500674

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.

Objectives of the Presentation:
The objectives of the Presentation are to talk about topics covering:
  • ISO 1491 requirements for FMEA
  • How can we apply FMEA to software design?
  • Levels of Software FMEA
  • System Functions Software FMEA
  • Software Functions FMEA
  • Identifying failure modes
  • Predicting causes of system failure
  • Risk analysis techniques
  • Developing risk acceptance criteria
  • Risk mitigation strategies
  • Mitigating risks to patients by designing for prognostics
  • Code level FMEA
  • FDA requirements for document control
  • Role of management in risk monitoring
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
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, 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 Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.

He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement and is Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He has done seminars on Risk Management, Process Validation, Software Reliability, Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System.
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