Risk Management of Medical Devices – ISO: 14971

What is risk: Combination of probability of occurrence of harm and the severity of that harm

Medical Device
Medical Device
M. Pharm., L.L.M., |
State Drugs Controller,
Food and Drugs Administration (FDA) Haryana |
Email ID: tanejamanmohan19@gmail.com
Manmohan Taneja

Last Updated on January 4, 2024 by The Health Master


This international standard specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device and evaluate the risks associated with these hazards, control these risks and monitor effectiveness of that control.

ISO: 14971 involves following steps:

  1. General requirements for risk management
  2. Risk analysis
  3. Risk evaluation
  4. Risk control
  5. Evaluation of overall risk acceptability
  6. Risk management report
  7. Production and post-production information

What is Risk:-

Combination of probability of occurrence of harm and the severity of that harm

What is Risk Management:-

It is the systematic application of management policies, procedures and practices for analysis, controlling and monitoring risk.

Also read another article of this author “License for Manufacturing and Import of Medical Devices”. Click here

Why Risk Management:-

  1. Regulatory requirement.
  2. To avoid product recall.
  3. To avoid market complaint.
  4. To avoid damage of product, market and company image.
  5. To ensure safety of Medical Devices.
  6. Product liability – avoid compensation.

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