Practical perspectives on regulatory compliance, quality systems, and navigating the medical device landscape.
The FDA's Quality System Regulation is now the Quality Management System Regulation (QMSR), aligned with ISO 13485:2016 and in force since February 2026. Here's what manufacturers need to know.
Read ArticleA quality management system should serve your team, not just satisfy auditors. We explore practical approaches to QMS design.
Read ArticleMDSAP audits cover five regulatory authorities at once. Use this checklist to identify gaps before your next audit cycle.
Read ArticleCorrective and preventive actions don't have to be overwhelming. Here's how smaller teams can manage CAPA effectively.
Read ArticleMoving from the legacy Quality System Regulation to the new QMSR requires more than paperwork. Here's a step-by-step checklist to guide your transition.
Read ArticleFDA has released its Fiscal Year 2027 medical device user fee rates, effective October 1, 2026, with double-digit increases across registration and premarket submissions. Here's what manufacturers should plan for.
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