Big changes are underway in U.S. medical device regulation. The FDA has officially begun its shift from the decades-old Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), and it’s going to impact how every FDA-facing company manages quality, documentation, and inspection readiness.

At AgentAstro, we help device innovators turn complex regulatory expectations into fast, focused submissions. That mission becomes even more important as QMSR changes the rules—and the mindset—around compliance.

Here’s what you need to know and how to stay ahead.

What Is QMSR, and Why Should You Care?

Since 1997, FDA’s QSR (21 CFR Part 820) has governed the quality systems for medical devices sold in the United States. In early 2024, the FDA finalized QMSR as its new standard, effectively adopting ISO 13485:2016 “by reference”—but with key modifications and no shortcuts.

You now have until February 2, 2026 to make the transition. After that date, QSR and its traditional inspection model (QSIT) will be fully retired. The QMSR will take over as the legal framework guiding inspections, quality management expectations, and your submission obligations.

Compliance Assumptions Are Risky

Let’s look at two real-world examples (names changed for privacy) that illustrate what’s at stake.

“Martin” runs quality assurance for a mid-sized device manufacturer in Ohio. He hadn’t been inspected in years, and when the FDA showed up, he was surprised to learn the old QSR references in their SOPs were out of date. The investigation flagged several compliance gaps—none of which would have been an issue under ISO 13485, but all of which mattered under U.S. law.

“Priya” works at a Canadian company with global ISO certifications. She assumed ISO 13485 would satisfy the FDA, but a pre-approval inspection revealed critical documentation and terminology mismatches. While they were technically compliant internationally, they weren’t meeting FDA expectations. It took a full rework of their internal systems and training to get cleared.

The takeaway? Even good quality systems can come up short if they’re not aligned with the QMSR.

Key Changes You Should Know

Here’s a snapshot of what’s shifting—and what you’ll need to adjust for:

• QMSR Is Now Law: This is not optional. If you’re submitting to the FDA, you need to comply—even if you're ISO 13485 certified.
• Old Terms Are Gone: Terminology like DHF (Design History File) and DMR (Device Master Record) is being phased out in favour of more flexible, principles-based documentation.
• Inspections Are Evolving: Management reviews, internal audits, and supplier assessments are now fair game for investigators. How you document problems—and how you resolve them—will be scrutinised.
• Certification ≠ Clearance: The FDA does not accept ISO certification as proof of compliance. The FDA assesses for legal non-compliance, not just system quality.

What You Should Do Next

Adapting to QMSR isn’t just about rewriting SOPs. It’s about recalibrating how your organisation thinks about quality, risk, and evidence. Here’s a practical roadmap you can follow:

1. Define Your Profile

Start with clarity: What kind of devices do you manufacture? What’s your organisation’s risk tolerance? How mature is your quality team? These answers should shape your transition approach—don’t default to a one-size-fits-all model.

2. Conduct a Targeted Assessment

Don’t just run a checklist. Compare your current system to QMSR requirements and the FDA’s latest commentary on its expectations. Pay special attention to areas that weren’t previously inspected or documented in a structured way—these are often where issues emerge.

3. Upskill Across Teams

Quality and regulatory aren’t the only departments affected. Design, manufacturing, and supply chain teams also need to understand what’s changing and why it matters. Focus on core concepts like design controls, risk management, and process validation—especially where U.S. requirements deviate from ISO.

4. Execute with Intent

Once gaps are identified, prioritise fixes with a clear implementation plan. Assign ownership, establish realistic timelines, and build in checkpoints. Make sure your management reviews include quality metrics that reflect QMSR priorities—not just legacy indicators. Think of this as building a compliance system that can withstand real-world pressure.

Where AgentAstro Fits In

Our mission is to eliminate guesswork and reduce the friction of regulatory submission. As QMSR reshapes what the FDA expects from your quality system, AgentAstro will help you:

• Align documentation with the new terminology and structure
• Map submission evidence to both ISO and FDA expectations
• Identify risk factors in predicate device lineage
• Flag inconsistencies in past submissions that may trigger inspection scrutiny
• Generate outputs that are built to satisfy the QMSR mindset

Our platform evolves with the regulations—so you don’t have to worry about falling behind.

The Bottom Line

The transition to QMSR isn’t just regulatory housekeeping. It’s a shift in philosophy—from rigid documentation to integrated risk thinking; from formality to function.

Companies that wait until 2026 to act may find themselves scrambling. Those that take a thoughtful, proactive approach now will be better positioned for inspections—and better equipped to scale.

AgentAstro is here to help you make that transition smooth, intelligent, and fast.

Let’s build smarter submissions—together.