The Use and Misuse Of FMEA In Medical Device Risk Management


  • How FMEAs are usually misused in medical devices
  • How to get most value from FMEAs
  • The correct way to conduct FMEA
  • How to get users involved in the FMEA
  • How to integrate FMEA in the risk management process
  • Eliminating design defects to reduce risks of recall
  • Eliminating manufacturing defects to reduce risk of recall
  • Eliminating maintenance mistakes using FMEA
  • New heuristics for getting fast results


Failure Mode and Effect Analysis can be used to assess the efficacy and efficiency of the device in actual use. Failure Mode Effects Analysis (FMEA) can have a number of variations the aim is to thoroughly review what can go wrong in use and what kind of misuses may be made. The device manufacturer must consider how to protect patients in case of misuse of the device such as ventilators and PCA pumps for pain control. Many patients have died from its inadvertent misuse. It is also important to consider processes such as packaging, sterilization, shipping of wrong kits, and labeling. These have many risks associated with them that could adversely affect the performance of the device.

Who should attend?

  • Senior management
  • Entire engineering staff
  • All technical managers
  • Test engineering staff
  • Regulatory affairs professionals
  • Marketing Managers
  • Service managers
  • Project Managers and engineers
  • Quality Assurance staff
  • IT professionals looking to make the design process efficient

Dev R


Dev, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps.


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