SUBSTANTIAL REVISIONS TO ISO 13485 QMS NOT NECESSARY FOR COMPLIANCE WITH QSR

Devices & Diagnostics Letter
KEYWORDS FDA / GMP / Industry News / ISO / QSR
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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).

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