ISO 14971 Standards

ISO 14971 is the key to effective risk management for medical devices.

ISO 14971 is the risk management standard for medical devices. This includes software as a medical device and in vitro diagnostic medical devices. It contains a structured approach for effective risk management.

ISO 14971 Medical Device Risk Management
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What Is ISO 14971?

ISO 14971 provides a framework to help medical device manufacturers manage risk. It is used to identify hazards, risks, ways to control those risks, and ways to effectively monitor those controls.

Benefits of ISO 14971

01

Industry-Specific Risk Framework

02

Works With Other ISO Standards

03

Better Prepared for the Future

ISO 14971 Certification

ISO certification adds credibility to a company worldwide. ISO itself doesn’t offer certification, but there are independent third parties that do. Even if a company doesn’t officially receive certification, they will still benefit from following the standard.

Medical Device Risk Management Process

Risk management is an ongoing process that requires companies to continually improve. This should be a thoroughly planned, documented and proactive process for improving a product’s design and usability during and after design and development. The different stages of risk management include the following:

  • Identify Hazards and Hazardous Situations

    A potential source of harm from using a device. This includes considering intended use and reasonably foreseeable misuse.

  • Estimate Risk

    Consider the probability of occurrence and the potential severity.

  • Evaluate Overall Acceptability of Identified Risks

    Create a risk acceptability matrix to determine if the risks are acceptable, if they are outweighed by benefits or if risk mitigation is required.

  • Establish Risk Control Measures

    These measures are meant for all risks, not just those deemed unacceptable. Also need to consider risks arising from the risk control measures.

  • Overall Residual Risk

    After the residual risk is deemed acceptable, the manufacturer must inform users of significant residual risks.

  • Risk Management Review

    Ensures that risk management has been appropriately completed, overall residual risk is acceptable and production and post-production measures.

  • Production and Post-Production Activities

    Collection and review of information to determine if additional risk management procedures are necessary.

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Avoid Risk by Being Prepared

Risk management is all about anticipating what might happen. This inherently means looking to the future. Risks in the medical device industry don’t just come at the product level — they can hit the whole industry or sectors. The key to managing this risk is learning about what the industry’s future holds.

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