From QSR to QMSR: Meeting FDA’s New Requirements

The countdown to QMSR compliance has started. Are you prepared to meet the challenge?

The new Quality Management System Regulation (QMSR) requires all U.S. medical device manufacturers to align the Quality System Regulation (QSR) with the ISO 13485 international standard by Feb. 2, 2026. For a resource that ensures you’ll ease through that transition without a hitch, you only need to read From QSR to QMSR: Meeting FDA’s New Requirements.

The FDAnews management report is based on a highly popular webinar led by regulatory expert Eric Henry, the esteemed senior quality systems and compliance advisor of the FDA & Life Sciences Practice at King & Spalding. The e-book is curated with all the essential information you’ll need to stay on task for the transition, details the FDA’s expectations, and explains why devicemakers may have to create separate versions of certain documents to comply with the legacy QSR while at the same time preparing for QMSR compliance.

Report Takeaways:

• Learn what led to the U.S. harmonization with ISO 13485.
• Find out how the QMSR incorporates ISO 13485.
• Understand where the QMSR differs from ISO 13485.
• Discover how the new regulation will impact inspections when the FDA replaces the current QSR-based Quality System Inspection Technique (QSIT).

Ensure you understand how to transition to QMSR compliance long before the deadline approaches, with From QSR to QMSR: Meeting FDA’s New Requirements.

About the Contributor

Eric Henry, senior quality systems and compliance advisor of the FDA & Life Sciences Practice at King & Spalding, is a 33-year veteran of the industry. Since 2018, he has provided advisory and consulting services focused on regulatory compliance, enforcement and policy matters for industries regulated by the FDA. Henry delivers guidance on FDA requirements to professionals in medical device manufacturing, including but not limited to quality systems requirements, inspection preparedness and post-market obligations.

Who Will Benefit

• All levels of leadership at medical device companies
• Quality assurance staff
• Regulatory affairs staff
• General counsel