Medical device quality is entering one of the most consequential transition periods in decades. With the FDA’s Quality Management System Regulation (QMSR) now in effect, expanding digital access to quality records, evolving ISO standards, and increased scrutiny of digital health technologies, 2026 will test whether quality systems are truly effective or merely compliant on paper.
Based on Rook Quality Systems’ direct experience supporting FDA inspections, regulatory submissions, and remediation efforts across the industry, the following five predictions highlight where regulatory expectations are tightening and where quality teams should focus now to reduce risk later.
Looking Ahead In 2026
The defining theme of medical device quality in 2026 is visibility. Regulators will see more, expect more, and tolerate less ambiguity. Organizations that invest now in disciplined, risk-based, and scalable quality systems will be best positioned to navigate inspections, submissions, and market expansion without disruption.
Rook Quality Systems helps medical device companies anticipate regulatory shifts, translate expectations into action, and build quality systems that stand up to scrutiny today, and in the years ahead.