On February 2, 2024, we finally got our long awaited Final Rule establishing the new Quality Management System Regulations (QMSR) from the FDA. The new QMSR is essentially the full implementation of ISO 13485 by incorporating the entirety of this standard by reference. With global regulatory frameworks becoming more difficult to manage in terms of compliance, harmonizing with the entirety of the ISO standard with FDA regualtions should have a net positive effect on industry.
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