In the second of a two-part series analyzing various stakeholder comments on the US Food and Drug Administration’s (FDA) proposed Quality Management System Regulation (QMSR), partner Dennis Gucciardo opined, “So what happens when a new revision of the standard is issued? I think that is obviously a huge question for everyone, considering FDA doesn't nearly move as fast as ISO. … I think FDA’s presumption is that there will be new revisions to the standard, but they will not be so dramatic such that it's going to cause for the solution that this is supposedly addressing, which is that ISO 13485 and the QSR are not structured similarly.”
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