With the deadline for the US Food and Drug Administration’s (FDA’s) long-stated goal of publishing its final Quality Management System Regulation (QMSR) by the end of December 2023 drawing near, partner Dennis Gucciardo spoke with Medtech Insight about the implementation of the rule, which seeks to align with international standards for medical device quality management systems. Discussing whether companies will find it easy or difficult to implement the final rule, Dennis stated that those with a global reach already have International Organization for Standardization (ISO) 13485 certification to comply with foreign jurisdictional requirements.
“But if you’re a US-only-based company, that’s going to be a bigger challenge,” Dennis said.
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