For medical device quality leaders, 2026 is the year the baseline for excellence is redrawn. The long-discussed digital transformation of quality is no longer a future concept but the new operational reality, codified in regulation. The go-live of the U.S. Food and Drug Administration’s (FDA) QMSR is the primary catalyst, yet it arrives alongside a cohort of equally demanding changes: the formalisation of artificial intelligence (AI) governance through Predetermined Change Control Plans (PCCPs), the mandate for deep software supply chain visibility with software bill of materials (SBOMs), the industry-wide pivot to computer software assurance (CSA), and the normalisation of remote audits. All these changes are taking place as enforcement activity is sharply accelerating, as evidenced by 38 warning letters issued by the FDA concerning quality system regulations (21 CFR Part 820) in FY2025 versus just 27 in FY2024.1
Success is no longer defined by managing these pressures in silos. It requires building a single, connected quality ecosystem capable of mastering them all at once. A brief from our strategic partners at MasterControl, explores the five trends that constitute this new baseline and offers an actionable framework for achieving a state of perpetual readiness and competitive advantage.
5 Critical Trends for Compliance and Innovation
- Regulatory Harmonisation: The QMSR Go-Live
- The most significant structural shift for U.S. medical device manufacturers is the FDA’s Quality Management System Regulation (QMSR), which fully replaces the legacy Quality System Regulation2 (QSR) and incorporates ISO 13485:2016. With the rule becoming enforceable on February 2, 2026, the time for theoretical planning is over.
- AI-Powered Quality Management & The Rise of PCCP
- AI in med tech quality is moving from pilot projects to governed, practical applications. The challenge isn’t just adopting AI, but managing it—especially for medical devices enabled with AI and machine learning (ML). This is where the FDA’s Predetermined Change Control Plan (PCCP) guidance becomes a critical framework for innovation and compliance.
- Cybersecurity & The SBOM/Vulnerability Exploitability eXchange (VEX) Mandate
- Cybersecurity has shifted from an IT concern to a core component of quality and regulatory compliance. With the FDA’s updated guidance now in effect, providing a software bill of materials (SBOM) is a standard requirement for premarket submissions, making software supply chain transparency non-negotiable.
- The Validation Shift From CSV to CSA
- The move from traditional, document-heavy computer system validation (CSV) to a risk-based computer software assurance (CSA) model is now a firm regulatory expectation. Driven by FDA guidance finalise in September of 2025, this trend redefines how the medical device industry approaches the validation of software used in production and quality systems.
- Remote Regulatory Assessments & The “Inspection-Anytime” Reality
- Initially a pandemic-era necessity, remote regulatory assessments (RRAs) have been formalised by the FDA as a permanent oversight tool. This solidifies an “inspection-anytime” reality, where a state of perpetual digital readiness is no longer an aspirational goal but a fundamental requirement for compliance for device manufacturers and their key suppliers.
For each trend, MasterControl reviews what’s changing & the 2026 outlook for quality and provides an action checklist for quality leaders.
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