A New Framework. Continued Accountability.
Effective February 2, 2026, the FDA's Quality Management System Regulation (QMSR) amended 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, alongside additional FDA-specific requirements. Medical-device manufacturers should evaluate how their existing quality systems align with the current requirements and prepare for the FDA's updated inspection process. Read the FDA's QMSR guidance
Where Could Your Quality System Be Exposed?
QMS documentation
Are your procedures and records aligned with applicable requirements?
Risk management
Are risk-based practices integrated into relevant quality processes?
Design and development
Are applicable design controls adequately documented and maintained?
CAPA and deviations
Can you demonstrate effective investigation, corrective action and follow-up?
Supplier quality
Are supplier qualification, monitoring and oversight appropriately controlled?
Inspection readiness
Can your team retrieve records, explain processes and demonstrate implementation?
Start With a Readiness Conversation.
Tell us about your organization and where you need support. We'll review your inquiry and discuss an appropriate assessment scope.
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