Launching a Medical Device in the US? Start With These Four Steps

Being ISO 13485 certified doesn't automatically make you FDA-inspection-ready. It gets you close, but the two frameworks are not a one-to-one match, and the gap between them is exactly where EU medical device companies run into trouble when they assume their existing quality system will carry over. This post covers what QMSR changed, where the real gaps still sit, and the four-step sequence Allyson Maur, partner at McGuireWoods, laid out during our recent webinar on medical device market entry in the US.

 Want the full walkthrough? Allyson M. Maur covers the QMSR gap and the four-step EU-to-US roadmap in detail in our webinar on going to market in the US with medical devices. Watch the full recording.

In February 2026, the FDA's updated Quality Management System Regulation (QMSR) took effect, replacing the previous QSR and moving closer to ISO 13485:2016.

The QMSR incorporates ISO 13485:2016 by reference, meaning that compliance with ISO 13485 is now a regulatory requirement for manufacturers marketing devices in the US, not just a voluntary alignment. For EU manufacturers already certified to ISO 13485, this is a significant step toward harmonization, but it does not make the two systems identical.

That harmonization is real progress, but it doesn't close the gap entirely. The QMSR incorporates ISO 13485:2016, so if your QMS is built around that standard, much of the foundation is already in place. Where the gap shows up is in what the FDA adds on top of ISO 13485: additional record-keeping requirements (including UDI traceability and complaint records), FDA-specific definitions that override ISO 13485, device labeling and packaging controls, and cross-references to other US obligations like Medical Device Reporting and Device Tracking. The inspection approach also differs, as FDA now uses a risk-based inspection process aligned to the QMSR, and a Notified Body ISO 13485 audit does not substitute for the FDA's own compliance assessment.

Your QMS is not a paper exercise

FDA investigators pull batch records, CAPA files, supplier qualification documentation, whatever paper trail demonstrates the system runs as described. Under QMSR, they also have more room to dig than they used to: where they once took a compliance committee's word that a meeting happened, they can now ask to see the minutes. Treating QMSR compliance as a documentation exercise is no longer sufficient; inspectors expect the underlying evidence, not just the policy describing it.

This is where your QMS and ERP carry real weight. FDA readiness means demonstrating consistent execution, traceability, and control, not just having procedures on paper. An ERP and QMS ecosystem enforces audit trail transparency, access controls, and supplier visibility systematically, controls that degrade fast when tracked by hand. The same goes for software bill of materials management, staying current rather than going stale, and for risk processes like failure mode and effects analysis. Post-market surveillance and CAPA benefit the same way, feeding telemetry data back into the system before a complaint has to surface it.

If your quality system was built for European compliance, it may still need additional controls, visibility, and traceability to meet FDA expectations. Finding those gaps now is far less disruptive than finding them during a submission review or inspection.

A four-step roadmap from the EU to the US

Once your quality systems are in order, four practical areas deserve your closest attention.

1. Confirm your designation (drug versus device) and if device, classification first.
   Before anything else, confirm your device's classification under FDA's risk-based framework (Class I, II, or III). This determines what type of premarket submission you'll need, whether that's an exempt pathway, a 510(k), a De Novo request, or a PMA. You can search the FDA's Product Classification Database to find how similar devices are classified. If your product sits at the boundary between a medical device and a drug or biologic, for example, a drug-coated device or a device that delivers a biologic , the question is different: you may need a formal Request for Designation (RFD) to determine which FDA center will take the lead. EU manufacturers familiar with the MDR's "ancillary medicinal substance" concept should note that the FDA uses a distinct mechanism, assigning a lead center based on the product's "primary mode of action" (PMOA). Getting this right early avoids building your regulatory strategy around the wrong pathway.
   
   
2. Pick your pathway based on classification and risk.
   Your pathway follows from your classification and the risk profile of your device. Choosing the pathway that looks fastest instead of the one that's correct is one of the more common ways companies end up delayed later rather than sooner.
   
   
3. Document everything, consistently and accurately.
   Not as a formality, but as the actual evidence an inspector will ask to see. This is the QMSR gap in practice: the documentation has to reflect real, ongoing quality activity, not a retrospective description of it.
   
   
4. Engage the FDA early and often.
   Pre-submission meetings carry real weight, not just a formality. They're how you confirm your classification assumptions, your pathway choice, and your QMSR readiness before you've committed resources to the wrong one. Companies bringing an existing EU product into the US, rather than launching in both markets simultaneously, tend to find gaps that need to be filled retroactively, and those are considerably harder to close after a product is already live.

One more point worth carrying into all four steps: don't try to cover every possible claim and intended use before you launch. Getting a safe, working product to market with an initial label, and expanding that label later, is often faster than trying to anticipate everything up front. Don't let a perfect submission become the enemy of a working one.

Similar requirements, different system

The EU and the US ask many of the same underlying questions: is your device safe, is it controlled throughout its lifecycle, and is the evidence there to prove it. Where they genuinely diverge is in clinical study design, particularly the population you test on and the endpoints you choose, and in how rigorously the FDA inspects the quality system behind your CE mark rather than accepting the mark itself as sufficient.

There's no need to fear the FDA, but it shouldn't be underestimated either. The companies that move fastest through this process are the ones that treat the FDA as a collaborator on classification, pathway, and QMSR readiness early, rather than working around it and hoping the gaps don't surface during inspection.

Your Next Step

Planning a US market launch and unsure whether your current systems support FDA expectations around traceability, change control, audit readiness, and documentation management? Start by assessing where your biggest operational gaps may exist before your submission or inspection timeline is underway. We'd be happy to discuss the challenges we're seeing across medical device companies and how organizations are preparing their ERP, QMS, and compliance processes for FDA readiness. Let's connect!

This wraps up our three-part look at bringing a medical device from the EU to the US. 
Catch up on the other two posts: Why Your CE Mark Won't Get You Onto the US Market and AI in Medical Devices: What the FDA's Predetermined Change Control Plan Actually Covers.