Designing Medical Devices for Safety with High Return on Investment


Instructor: Dev Raheja
Product ID: 706271
Training Level: Intermediate to Advanced

  • Duration: 60 Min
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.
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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
Instructor Profile:
Dev Raheja

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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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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