Risk Management according to ISO 14971

In a fast-paced world, the risks companies are exposed to have to be managed in order to continue to grow and to develop, to evolve quickly. Effectively managed risks help companies achieve their goals.

Products that are developed following quality standards, have improved the quality of life for thousands of people. The idea of improving the quality of life is the premise of product risk management.

If you are developing medical devices in this day and age, you absolutely must have an established Risk Management process that is defined, documented, and implemented.

Risk Management

The Risk Management process includes:

  1. Risk Management Planning – should identify the risk management activities company anticipate and plan throughout the product’s lifecycle.
  2. Risk Analysis – systematic use of available information to identify hazards
  3. Risk Evaluation – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
  4. Risk Controls – process in which decisions are made and measures implemented by which risks are reduced to specified levels
  5. Overall Residual Risk Acceptability – identifying the acceptability of risks that remain after risk control measures have been taken
  6. Risk Management Reporting – the summarized result of all steps in risk management processes
  7. Production & Post-Production Information – a system to collect and review information about the medical device in the production and post-production.

A Risk Process describes the steps companies need to take to identify, monitor and control risk. Within the Risk Process, a risk is defined as any future event that may prevent them to meet their team goals. A Risk Process allows companies to identify each risk, quantify the impact and act to prevent it from occurring and reduce the impact of it. The risk management process is not a single step to be performed during the development of the medical device, but an on-going activity that is constantly and consistently applied throughout the entire life of the medical device from beginning to drawing of the medical device from the market.

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3 replies to “Risk Management according to ISO 14971”

  1. Matthias Reade says:

    We performed FMEA till now and our Risk analysis is verified by auditors inspection of our technical file. Now, we would like to find software which can help us to perform a risk analysis. Of course, based on ISO 14971 and MDR requirements. Can someone recommend me some solution?

  2. Nora Walters says:

    Does the ISO 14971 covers the complete requirements of MDR, MDD, FDA risk assessment? Also, does it provides a guidance how to properly treat residual risk to be compliant with the directives, regulative and FDA either?

    1. Ben D. says:

      Hi Nora! I would say, that ISO 14971 basically gives you the right direction how to handle risks and in the same way to cover all risk assessment requirements from each regulatory and standard perspective as it is expected.

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