Author name: Clara Fication

Clara Fication has spent more than three decades helping medical device companies navigate the ever-shifting landscape of FDA regulation — from the original QSR to the freshly minted QMSR. Clara writes about FDA requirements the way a good mentor explains them: clearly, honestly, and without the panic that comes from reading the Federal Register cold. She believes that compliance is not the enemy of innovation — it's the thing that makes innovation trustworthy. When she's not translating regulatory Latin into plain English, Clara enjoys criticizing science fiction shows, maintains that a well-written SOP is a form of kindness, and considers coffee a critical component of any compliant quality system.

QMSR Scope: Who This Applies To (and a Few Surprises)

Clara Fication / March 5, 2026

The QMSR’s scope section looks simple — it’s one page in the regulation. But understanding exactly who is covered, and how the QMSR handles some edge cases the old QSR left fuzzy, is worth your time. Clara walks you through it.

The QMSR Is Here: What FDA’s New Quality Management System Regulation Means for You

Clara Fication / March 2, 2026

FDA’s new Quality Management System Regulation took effect February 2, 2026. Here’s a clear-eyed look at what changed, what it means for manufacturers already under ISO 13485, and what to expect from this section-by-section series.