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).

FAQs

What is the current ISO 14971 standard?

ISO 14971 content is being added. Stay tuned.

Is ISO 14971 required?

ISO 14971 content is being added. Stay tuned.

Does FDA recognize ISO 14971?

ISO 14971 content is being added. Stay tuned.

What is the difference between ISO 13485 and ISO 14971?

ISO 14971 content is being added. Stay tuned.

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