ISO 14971: Medical devices

ISO 14971 sets guidelines for risk management in the manufacture of both software and in vitro medical devices. It outlines a process for ensuring safety throughout a product’s lifecycle by identifying, evaluating, controlling, and monitoring potential hazards.

These hazards include those related to:

• Biocompatibility
• Data and systems security
• Electricity
• Moving parts
• Radiation
• Usability

An ISO 14971 certification is often necessary for manufacturers of medical devices, including those involved in their design, production, and distribution.

While not necessarily mandatory by law, the standard does ensure that medical devices meet international safety standards by effectively managing and mitigating risks throughout a device’s lifecycle. As such, it is often required by regulatory bodies and industry standards around the world.

To get certified in ISO 14971, an organization typically develops and implement a risk management plan that aligns with the standard. The organization will then conduct an internal audit.

If successful, the organization will contact a certification body, then schedule and undergo an external audit. Once the external audit has been passed, the organization will receive an ISO 14971 certification.

ISO 14971 certifications are typically valid for three years, after which time an organization must undergo another external audit. This ensures that your organization’s risk management plan is kept updated and aligned with the ISO 14971 standard.

ISO 14971 certifications offer several benefits to organizations. Some key advantages include the following.

Implementing ISO 14971 may pose several challenges to organizations. They include the following.

Here are a few tips for preparing for an ISO 14971 certification:

• Purchase and read the ISO 14971 standard in full
• Define a clear risk management process that is aligned with the ISO 14971 standard
• Perform a skills gap analysis to determine the skills your organization needs to implement and adhere to an ISO 14971-approved medical device risk management process

For more information and guidance on ISO 14971 certification, you can refer to the following resources.

International Organization for Standardization (ISO). The ISO 14971 page on the official ISO website provides the ISO 14971 standard document, news updates, and additional resources.

Accredited certification bodies. To pursue ISO 14971 certification, you can reach out to accredited certification bodies that offer certification services in your region. These bodies have the expertise to guide you through the certification process. You can find a list of accredited certification bodies on the website of the International Accreditation Forum (IAF).

Regulatory authorities. Various regulatory authorities worldwide, such as the U.S. Food and Drug Administration (FDA) in the United States or the European Food Safety Authority (EFSA) in the European Union, are closely related to ISO 14971. These regulatory bodies may use ISO 14971 as a reference or align their regulations with the standard, as well as offer scientific advice and risk assessments for medical devices.

AG5 stores all certifications in the cloud, providing all authorized personnel with access to the right version of approved certifications. This helps you easily keep track of all data and documentation related to an ISO 14971 certification across your organization.

Using AG5’s skills management software, you can monitor the status of any type of certification that is relevant to your workforce, leveraging intuitive dashboards that provide you with a clear understanding of exactly what is needed to keep your employees skilled and safe.