What is ISO 14971?

ISO 14971 Definition

ISO 14971 is the international standard that establishes the requirements for risk management for medical device companies. It established guidance for risk analysis, evaluation, control and management, and also specifies procedures to review and monitor throughout production and post-production. The ISO 14971 requirements are harmonized with Europe’s medical device regulations (MDR).

What is ISO 14971


What is the current ISO 14971 standard?

The current standard is ISO 14971:2019.

*Source: https://www.iso.org

Is ISO 14971 required?

Although there is no official certification process for ISO 14971, it is considered good manufacturing practice to comply with the standard. In addition, regulatory agencies such as the FDA use ISO 14971 as an indicator of a manufacturer’s commitment to safety, and it is essentially audited as part of the ISO 13485 QMS certification.

*Source: https://www.orielstat.com

Does FDA recognize ISO 14971?

The U.S. Food and Drug Administration (FDA) accepted ISO 14971:2019, a recently revised International Organization for Standardization (ISO) risk management standard for medical devices, along with over 100 other consensus standards, in late December 2020.

*Source: https://www.raps.org

What is the difference between ISO 13485 and ISO 14971?

ISO 13485 focuses on quality and customer requirements for medical devices, whereas ISO 14971 focuses primarily on safety, security, and risk associated with the use of medical devices.

*Source: https://13485store.com

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.