Risk Management for Medical Devices: ISO 14971:2019


What types of risks are covered by Risk management?

It covers the harms related to patients, users or/and environment.

What is the difference between Design controls and Risk management?

Design Controls prove that the Medical Device is safe, effective and meets the indications for use, and help reduce product risks. In parallel, Risk Management intends to identify, evaluate, analyze, assess and mitigate potential product issues. Indeed, there is a correlation between these two notions, however, the perspectives are different.  

What are the steps of the Risk Management process?

A risk Management file must include:

  • Risk management Plan
  • Risk Analysis
  • Risk Evaluation
  • Risk control
  • Evaluation of Overall risk acceptability
  • Risk Management Report
  • Production and Post-Production Information

These fields define the steps of the Risk Management process.

Author: Alix Auter, Life Science Consultant KVALITO 

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