Build a Quality Management System that scales with your organization — one that satisfies FDA QSR/QMSR, EU MDR, and ISO 13485:2016 while staying practical enough for your team to operate every day.
A QMS that satisfies a regulatory inspector/auditor is the same QMS that the team has to use every day to design, build, distribute, and support your device. Those two goals aren't always aligned — and a lot of Quality Management Systems fail because they were built for one and not the other.
We design Quality Systems that work both ways: structured enough to satisfy regulators and notified bodies, but practical enough that your team can operate them without constant friction. The result is a QMS that holds up under audit and continues to function once we're gone.
Whether you're building a QMS from scratch, remediating one that's drifted, or scaling one because your organization has outgrown it, we approach the work the same way: understand where you want to go, and design the tools to help you get there.
Complete customized QMS implementation built for your entity type, products, and markets.
Assess your existing QMS against ISO 13485, FDA QMSR, MDSAP, and identify gaps before they become findings.
Update procedures and documentation as needed to close gaps and meet current requirements.
Author the Quality Manual and supporting procedures that set the architecture for everything else.
Handle internal audits as required by ISO 13485 and FDA QMSR — including audit planning, execution, and reporting.
Mock audits and preparation for notified body, FDA, MDSAP, and customer audits.
Establish or refine the management review program — the leadership-level oversight that drives QMS effectiveness.
Build the feedback loops that keep your QMS effective over time, not just at the next audit.
Create and manage CAPAs that come out of audits, post-market surveillance, and complaints — designed to actually prevent occurrence or recurrence.
QMS-level risk management framework integrated with product risk management per ISO 14971.
Update and maintain benefit-risk analyses as part of risk management and post-market evaluation.
Connect post-market data feedback into CAPA, risk management, and management review — closing the QMS loop.
Whether you're building, remediating, or scaling — schedule a no-cost consultation and we'll help you scope what's needed.
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