Revised Device Quality System Regulation Would Incorporate ISO 13485 Requirements by Reference

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Revised Device Quality System Regulation Would Incorporate ISO 13485 Requirements by Reference

Some Current QS Mandates Are Retained in Proposed Rule; Firms Would Have One Year To Comply

Dennis Tosh

February 22, 2022 at 04:06 PM EST

The FDA Feb. 22 released its long-awaited proposed rule to align the agency’s quality system (QS) regulation more closely with ISO 13485, the internationally recognized consensus standard for device quality management systems (QMSs). The proposed rule, which was published in the Federal Register Feb. 23 (87 Fed. Reg. 10119), would amend the FDA’s QS regulation, 21 C.F.R. Part... Read More

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Revised Device Quality System Regulation Would Incorporate ISO 13485 Requirements by Reference

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