FDA's Quality Management System Regulation (QMSR) replaces the Quality System Regulation (QSR), harmonizing with ISO 13485:2016 while maintaining FDA-specific requirements. This fundamental shift affects every medical device manufacturer selling in the US. While harmonization promises efficiency, the transition demands careful planning to maintain compliance during change.
QMSR audits require deep understanding of both frameworks—where they align, where they diverge, and what's genuinely new versus repackaged. Organizations must map current QSR systems to QMSR requirements, identify gaps, and implement changes without disrupting operations or compliance.
Our QMSR specialists include former FDA officials involved in the regulation's development and industry experts who've guided ISO implementations. We provide the insight needed for smooth transitions.
The medical device industry is on the cusp of a significant regulatory shift as the FDA harmonizes the QSR with ISO 13486:2016. Is your organization ready? Our new white paper and gap analysis worksheet are your essential guides for transitioning from the FDA's QSR to the new QMSR. Sign up for a paid subscription to our Insider Newsletter for access to both of these resources.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.