Software Reliability and Safety Fundamentals for Medical Devices

Duration: 60 Minutes
Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. The FDA's Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report on June 15, amid reports of a compromise of a Web site used to distribute software updates for hospital respirators. According to the Agency, the absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences. Recent research done on the security of medical devices by a team of researchers would accept unsigned, counterfeit software updates.
Medical Device Software
Instructor: Dev Raheja
Product ID: 500533

Why Should you Attend:
Software risk analysis is more difficult than hardware analysis because of thousands of interactions within and with other devices. Intelligence in most devices is a function of several systems working together to produce properties and behavior different than those of components. The disciplines of gathering such intelligence are often missing. This is one reason for increase in device recalls. Most manufacturers have not applied rigors of hardware risk analysis to software designs. The same methods apply to software even though there are differences in software and hardware. Software requirements analysis, PHA, FMEA, FTA, and HAZOP are great tools for software safety.

Objectives of the Presentation:
  • Learn how to use risk analysis tool on software design
  • Learn the principles of software safety
  • Learn the principles of design for reliability and trustworthiness
  • Learn how to write sound software specifications
  • Safety flaws in the software specifications
  • Writing good safety requirements
  • Writing good reliability requirements
  • Heuristics for designing for trustworthiness
  • Software safety analysis
  • Safety analysis tools
  • Analyzing active safety
  • Safety mitigation methods
  • Designing for software reliability
  • Software Failure Mode and Effects Analysis
  • Fault Tree Analysis for complex mitigations
  • Software qualification testing for safety
  • Software qualification testing for reliability
  • Examples of best practices
Who can Benefit:
  • Senior Management
  • R & D Managers and Engineers
  • Product Development Managers and Engineers
  • Software Managers and Engineers
  • Reliability Managers and Engineers
  • Corporate Legal Staff
  • Marketing Managers
  • Service Engineering Managers
  • Quality Assurance staff
  • Regulatory Affairs staff
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 Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • 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.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • 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 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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