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Home » Inconsistencies between FDA’s QSR and ISO 13485 yield a complicated navigational task
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Inconsistencies between FDA’s QSR and ISO 13485 yield a complicated navigational task

July 23, 2021
By Mark McCarty
The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort.
BioWorld MedTech Regulatory U.S. FDA

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