Designing Medical Devices for Safety with High Return on Investment

Dev Raheja

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This webinar will cover the new paradigms for designing safe products. It will discuss how to plan for Zero Defects at little or no cost resulting in high return on investment. It will cover real industry examples from the instructor’s experience.

Why Should You Attend:

  • Do you know that the number of medical device recalls have been steadily going up for the last 20 years?
  • Are all R&D managers and engineers trained in the science of proactively predicting safety mishaps and designing them out?
  • Do all design and manufacturing engineers have the same training?
  • Do you prevent manufacturing faults that can result in harm to users?
  • Do you have verification and validation strategies for identifying new safety concerns?
  • Do all employees have training on “Be Lean, Not Mean”

The biggest reason for medical device recalls is that most specifications miss about 60% requirements. You will learn how to write good performance specifications by conducting the risk analysis the right way.

The webinar will teach you how to identify safety hazards proactively, and how to think creatively so that the cost of preventing unsafe incidences is very low compared to the future savings.

Areas Covered in the Webinar:

  • Reasons for increasing number of recalls every year
  • Writing robust specifications for safety
  • Conducting risk analysis prior to approving the specifications
  • Design strategies for preventing safety mishaps
  • Failure Mode and Effects Analysis
  • Fault Tree Analysis
  • Event Tree Analysis
  • Strategies for preventing manufacturing faults related to safety
  • Accelerated testing for safety
  • Verification for safety
  • Validation testing for safety
  • Management policy for safe devices

Who Will Benefit:

  • Top management
  • R&D engineers and managers
  • Manufacturing engineers and managers
  • Product safety staff
  • Quality Assurance staff
  • Marketing managers
  • Service Engineering managers
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Dev Raheja, Risk Management Consultant, Independent

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls, Design for Reliability, and Assurance Technologies, is an international risk management, reliability, and system safety consultant for government, commercial and aerospace industry for over 30 years. His clients include Army, Navy, Air Force, NASA, Siemens, Eaton, Boeing, Lockheed, Northrup Grumman, General Motors, Prior to becoming a consultant in 1982 he worked at GE 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. He teaches Design for Reliability courses at the University of Maryland for degree programs in Mechanical Engineering and Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, and former chair of the Reliability Division. He is a Senior Member of IEEE. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. His served as Vice president of the International System Safety Society where he received the Scientific Achievement Award and the Educator-of-the-Year Award. He served on the Board of Directors for the Annual Reliability and Maintainability Symposium for more than 10 years.

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