Software FMEA for Medical Devices

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• Software FMEA for Medical Devices

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Instructor Profile
• Dev Raheja, MS,CSP, author of the
  forthcoming book 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 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.  

www.onlinecompliancepanel.com 510-857-5896
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• Description
• 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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. 
• Who can Benefit?
• Senior management
• Software development managers and engineers
• Hardware managers and engineers
• Quality Assurance staff
• Regulatory affairs staff

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Get certification of attendance.
• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com