QMSR & FDA Changes — Familiarization Course

QMSR & FDA Changes — Familiarization Course (90 min, self-paced)

Covers the regulatory changes FDA made up to 2 February 2026, when the Quality Management System Regulation (QMSR) took effect—especially incorporation of ISO 13485:2016 by reference, and what that means in an actual FDA inspection. Also treats the new inspection program (CP 7382.850), the record-access change, expanded unannounced foreign inspections, and the risk-based inspection shift.

For: quality-management and quality-assurance consultants who know ISO 13485, TÜV/notified-body audits, and MDSAP, but whose facilities haven't seen an FDA inspection in about years. You're about to, if you didn't suspect already, just a question of when. Assumes solid knowledge of ISO 13485 and focuses on what FDA adds on top of it.

A high-flux dialyzer (21 CFR § 876.5860, Class II, cleared via 510(k)) runs through the examples and job aids as a concrete case — illustrative, not the subject.

On completion: explain the QMSR and how it differs from the former QSR, conduct a gap assessment against the QMSR's U.S.-specific requirements, and prepare a facility for a CP 7382.850 inspection, unannounced scenarios included.

18 formative questions across 7 sections, a 30-question final assessment, 80% to pass. Reflects FDA regulations and guidance current as of June 2026.