QMS.Coach

If you're a medical device startup building your first quality management system, you have an advantage: you can build it right from the start. You're not transitioning from QSR to QMSR—you're starting fresh with QMSR requirements as your foundation.

Supplier quality management under QMSR is more explicitly risk-based than under QSR. ISO 13485:2016 Clause 7.4 requires

With the February 2, 2026 deadline approaching, companies are rushing to implement QMSR requirements. Speed creates risk. We're already seeing patterns of mistakes that will likely result in FDA findings—or worse, will require expensive rework after the deadline.

FDA inspections after February 2, 2026 will look different. Inspectors will reference ISO 13485 clause numbers instead of QSR sections. They'll request records that were previously exempt—management review minutes, internal audit reports, supplier audit documentation.

If you're ISO 13485:2016 certified, you might assume QMSR transition is automatic. After all, QMSR incorporates ISO 13485:2016 by reference. Same requirements, same regulation—right? Not quite. Your certification demonstrates compliance with ISO 13485:2016, but QMSR adds FDA-specific requirements