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Home » SUBSTANTIAL REVISIONS TO ISO 13485 QMS NOT NECESSARY FOR COMPLIANCE WITH QSR
SUBSTANTIAL REVISIONS TO ISO 13485 QMS NOT NECESSARY FOR COMPLIANCE WITH QSR
January 23, 2004
Devicemakers do not have to substantially revise ISO 13485-compliant quality management systems (QMS) to meet the FDA's quality system regulation (QSR) because the standard does not set up conflicting requirements, according to David Feigal, director of the Center for Devices and Radiological Health (CDRH).