Last year, the FDA finalized a rule that will reshape the compliance infrastructure for medical device manufacturers in the US. After years of consultation, the agency confirmed that it will overhaul its Quality Management System Regulation (QMSR), known as 21 CFR Part 820, which sets requirements for how medical devices are designed, manufactured and distributed. The updated rule brings it into alignment with ISO 13485, the international standard already required in many global markets. ISO 13485 certification is not mandatory under QMSR, but compliance with its requirements is. The change won’t take full effect until February 2, 2026, but its implications are already starting to influence how regulatory teams design quality systems and assess risk.
Medical device manufacturers now face a compliance reckoning that’s closer than many realize. The two-year transition window may sound generous, but in practical terms, it’s already closing. Many manufacturers are already moving to align their systems to avoid last-minute challenges. For companies that have been operating under the FDA’s legacy framework, especially smaller manufacturers, this is a fundamental shift that will determine future market access. Those that wait too long risk scrambling to retrofit their quality systems and could face costly gaps that delay or derail product approvals.
What the QMSR means for different manufacturers
Picture two medical device companies preparing for the same regulatory change.
Company A has built its quality system around ISO 13485. Their internal processes are well-documented, their data is structured, and their teams are trained to demonstrate traceability at every stage of product development. When the FDA’s updated QMSR takes effect, they’ll need to make a few adjustments, but the foundations are already in place.
Company B, however, has focused exclusively on meeting basic FDA requirements. Their quality system was built for a domestic audience, not a global one. Now, they’re facing months of work to redesign processes, implement new documentation systems, and train staff, all while continuing to manufacture and ship products. For smaller teams without dedicated compliance specialists or access to flexible quality management tools, the task can feel overwhelming.
This scenario is already playing out across the industry. Smaller manufacturers, especially those that haven’t previously needed to consider global standards, face the steepest learning curve. They’re being asked to meet a higher regulatory bar, often without the resources to scale quickly or bring in outside support.
Contract manufacturers are navigating a different kind of complexity. Their compliance depends on the companies they supply. If a client hasn’t updated their quality requirements to reflect ISO 13485 alignment, it introduces a vulnerability – one that can delay product clearance or trigger audit findings across the supply chain. But once companies make it through the transition, they’re in a stronger position. A unified quality system means fewer surprises during inspections and fewer roadblocks when entering international markets. For US-based manufacturers with global ambitions, this shift replaces a patchwork of regulatory frameworks with a single, globally recognized standard.
AI Is rewiring the audit process
The FDA has also been exploring the use of AI to pre-assess audit readiness and identify high-risk facilities. This doesn’t eliminate human inspectors, but it does change how inspections are conducted. Structured data is beginning to drive audit targeting, scope, and depth, prompting quality teams to rethink how they gather and store compliance evidence.
Manufacturers will soon face audit models that blend algorithmic pre-screening with on-site verification. These hybrid inspections demand a different kind of preparation. Checklists alone won’t suffice – instead, quality teams will need to prove that their systems operate as intended and produce predictable outcomes under scrutiny. That requires internal data maturity and a clear audit trail at every stage of the product lifecycle.
This transition is especially consequential for manufacturers working with software-based or connected devices. Unlike traditional electromechanical products, these systems evolve continuously post-market. AI-enabled audits are more likely to flag inconsistencies in update procedures, patch management, or cybersecurity practices – areas that haven’t always received consistent attention in audit preparation.
Why compliance needs a seat at the design table
Compliance decisions made during the early stages of design and development will reduce downstream rework and improve speed to market. The longer manufacturers delay ISO 13485 alignment – or overlook how AI might reshape audit scrutiny – the more difficult it becomes to retrofit quality systems after production begins.
Strategic integration means eliminating the late-stage surprises that cause delays, trigger nonconformities, or expose safety risks. And as regulators become more technologically sophisticated, reactive compliance models won’t keep pace. The most effective teams are those that treat regulation as a moving target and treat regulatory planning as a key input into product development.
The two-year transition window may sound generous, but in practical terms, it’s already closing. Most manufacturers will need to reassess how their quality system operates in practice, and move quickly to close any structural gaps, especially in companies with legacy infrastructure or global supply chains. For many, the QMSR shift will surface structural weaknesses that were easy to overlook under the old model.
At the same time, AI is advancing much faster than regulation. Within three years, most manufacturers can expect their compliance posture to be evaluated – at least in part – by tools they didn’t anticipate when their current quality system was designed. Preparing for that shift now is the difference between staying audit-ready and falling behind. Regulatory harmonization and AI-assisted audits are converging, and both require the same foundational change – a more deliberate, proactive approach to quality and compliance.
Dr. Yuan Li
Dr. Yuan Li is Director of Medical Business for DQS.
