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Home » What to Expect from ISO 13485 Harmonization
What to Expect from ISO 13485 Harmonization
August 4, 2022
The FDA in February 2022 published its long-awaited proposed rule to officially harmonize its Quality System Regulation (QSR) for medical device manufacturers with ISO 13485, the international standard for quality management systems. The agency had first announced its intention to update the QSR in May 2018.