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Home » Implementation timelines a key concern regarding FDA proposal to align with ISO 13485
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Implementation timelines a key concern regarding FDA proposal to align with ISO 13485

May 24, 2022
By Mark McCarty
The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly administrative issues associated with this proposal. Several of those who have commented to the docket have expressed misgivings as to the proposed 12-month compliance deadline upon issuance of a final rule.
BioWorld MedTech Regulatory U.S. FDA

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