Medical Device Risk Analysis

Medical Device Risk Analysis as per ISO 14971 is the latest international standard for the Medical Device Risk Management Process for the Medical Devices (As per Harmonized Standards). The Risk Management Process contains 3 important parts:

  • Risk Analysis
  • Risk Evaluation
  • Risk Control

The Risk Analysis is the starting phase of the risk management process for a medical device. A medical device risk management plan is determined and implemented. The three important stages of the Risk Analysis Process are below.

  • Identification of the intended use and characteristics related to the safety of the medical device.
  • Identification of known or foreseeable hazards
  • Estimation of the risk for each hazardous situation

Risk management Procedure and Report

Thus, risk analysis is the systematic use of the available information to estimate the risk in the identified hazards. The risk analysis activities and the results are recorded in a risk management file. Some of the Risk Analysis techniques explained in the standard are:

  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Mode and Effects Analysis (FMEA)
  • Failure Mode, Effects and Criticality Analysis (FMECA)
  • Hazard and Operability Study (HAZOP)
  • Hazard Analysis and Critical Control Point (HACCP)

Depending on the intended use, characteristics, present stage of development of the medical device, one or more of the above techniques can be used for the risk analysis.

Medical Device Risk Management plan

Risk management activities must be planned for every CE Marking project before the initialization of risk analysis activities.

  • The planning of risk activities shall be coherent with the risk class of the device and Intended use.
  • Putting together your risk management team.
  • Important, list the deliverables and reviews of each phase of the project
  • Suggestions for overall improvement as per Notified Body requirements.

Role of Consultants in Risk Management File

  • Review the hazards and control measures taken
  • Development of annexures as per standard
  • Guidance and suggestions for closing the identified GAPS.
  • Suggestions for overall improvement as per Notified Body requirements.
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