Posts tagged quality system regulation
FDA Recognizes It's Time for QSR 2.0

FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

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