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Is the medical device certification management system in the United States based on ISO 13485?
Category：企业动态 Date：2025-01-03 17:28:35 Author: Source:
The medical device certification management system in the United States is not directly based on ISO 13485, but it shares some similarities. ISO 13485 is an international standard for quality management systems (QMS) specifically for medical devices. In the U.S., the FDA's regulations govern the certification of medical devices, and these are primarily based on the Federal Food, Drug, and Cosmetic Act (FDCA) and related FDA regulations, particularly 21 CFR Part 820, which sets requirements for QMS similar to ISO 13485.

The medical device certification management system in the United States is not directly based on ISO 13485, but it shares some similarities. ISO 13485 is an international standard for quality management systems (QMS) specifically for medical devices. In the U.S., the FDA's regulations govern the certification of medical devices, and these are primarily based on the Federal Food, Drug, and Cosmetic Act (FDCA) and related FDA regulations, particularly 21 CFR Part 820, which sets requirements for QMS similar to ISO 13485.

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While ISO 13485 is not a requirement for FDA certification, many medical device manufacturers use ISO 13485 as their QMS framework because it aligns closely with FDA requirements and can help streamline the approval process. Companies that comply with ISO 13485 typically find it easier to meet FDA’s QMS requirements, and ISO 13485 certification is often seen as beneficial for ensuring product quality and safety during the FDA’s review process.

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