How to implement of FMEA with ISO 14971

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How to implement of FMEA with ISO 14971?
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• Failure Mode and Effects Analysis (FMEA) is a
  core aspect of risk management and risk analysis
  in medical devices. FMEA is essentially about
  analyzing the reasons for which a problem arises
  and the effects it has on the system.
• In the field of medical devices, it is absolutely
  critical to understand the failure mode and
  effects because the consequences of not doing
  this can be disastrous and many times, even fatal.

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FMEA
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Required, but not clear about the steps

• The FDA only broadly states that risk management
  has to be built into the manufacturing process.
• This leaves medical device manufacturers in a
  kind of quandary, because although the FDA is
  clear about the requirement for risk management
  there is no clear-cut guideline on how this needs
  to be carried out.

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• This leaves the implementation of FMEA in medical
  devices something that is at the discretion of
  the medical device company.
• The FDA's Final Rule on cGMP Quality System
  Regulation (QSR) is, to quote its own words,
  "...less prescriptive and gives the manufacturer
  the flexibility to determine the controls that
  are necessary to be commensurate with risk"

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• In other words, there is no specific guideline on
  risk management, using which medical device
  manufacturers can decide the ways and processes
  of implementing risk management.
• The guideline is all the more vague about risk
  analysis approaches and procedures like FMEA.

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• Since the guidelines on medical devices FMEA are
  rather general
• Medical device companies that implement FMEA have
  to go by a buzzword implementing FMEA at every
  level.
• In this regard, they can work complementarily
  with ISO 14971, whose guidelines relate to risk
  management.

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