Software FMEA for Medical Devices

Software FMEA for Medical Devices


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About The Event


The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device.

The variants can be User Level FMEA, Subsystem FMEA, Interface FMEA, Module Level FMEA, and Code Level FMEA. Marketing should lead the effort on User Level FMEA. 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 devices Many patients have died from the inadvertent misuses. It is also important to include the analysis of software trustworthiness, safety, reliability, and maintainability. These have many risks associated with them that could adversely affect the performance of the device. 

Why should you Attend: The ISO 14971 and its risk analysis tool FMEA has been recognized by FDA, and in Europe, for risk mitigation of medical devices. Compliance with ISO 14971 will therefore be crucial not in meeting regulatory requirements but also as a most important part of design control.

The FDA reviews the results of the FMEA as preview to device recalls, during adverse event analysis, and complaint investigations. FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a millions of lines of code. This difficulty can be increased by the number of possible operating modes, as well as by including consideration of software change control policies. Therefore a thorough understanding by the entire staff is critical in efficient FMEAs. 

Areas Covered in the Session:

  • Software FMEA fundamentals
  • Frequent mistakes in FMEA
  • Different levels for FMEA
  • System Functions FMEA
  • Subsystem level FMEA
  • Module level FMEA
  • Code level FMEA
  • Interface FMEA
  • Severity rating scale
  • Probability rating scale
  • Risk assessment
  • Risk mitigation
  • Software change control
  • Configuration accounting
  • Post control risk evaluation
  • Example of a good Software FMEA
  • Reporting the results of FMEA
  • Using FMEA as a living document

Who Will Benefit:
  • Software Managers
  • Software Developers
  • Hardware Engineers and Managers
  • System Engineers
  • Quality Engineers
  • Quality Auditors
  • Medical staff evaluating risk, safety or effectiveness
  • Quality or regulatory staff assigned to complaint,
  • Marketing Managers
  • Device Users


Speaker Profile
Dev Raheja PE, CSP, is a system safety practitioner, consultant and trainer for over 25 years.