Risk Management for Medical Devices

Risk Management for Medical Devices

“ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this standard are applicable to all stages of the life-cycle of a medical device.”

Key things include:
  • Reduce risks “as far as possible” (versus “as low as reasonably practicable”) for all risks
  • Establish risk control measures for all risks (not just the unacceptable ones)
  • Need for a risk / benefit analysis for all risks
  • Risk reduction has to be more than information provided to the user (e.g. labeling and instructions for use)

Design Controls & Risk Management

Design Controls are intended to demonstrate that a medical device has been:
  • Designed to address the needs of users and patients.
  • Designed to meet inputs and requirements.
  • Proven to meet applicable standards.
  • Meets performance criteria.

Your Design Controls will prove that your medical device is safe for use.

The intent behind Risk Management is to identify, evaluate, analyze, assess, and mitigate potential product issues.

There is a very strong correlation and relationship between Design Controls and Risk Management.

With Design Controls, you also identify, evaluate, analyze, assess, and mitigate potential product issues.

Design Controls and Risk Management address design, development, and manufacturing of medical devices from slightly different perspectives.



Risk Management Process Overview
Medical device Risk Management requires top management involvement. It requires that a company establish a

Risk Management Policy.

The process itself includes:
  • Risk Management Planning
  • Risk Analysis
  • Risk Evaluation
  • Risk Controls
  • Overall Residual Risk Acceptability
  • Risk Management Report
  • Production & Post-Production Information