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# FDA’s Early QMSR Priorities Seen
- URL: https://www.fdaweb.com/fdas-early-qmsr-priorities-seen/
- Published: 2026-04-28T12:00:00.000Z
- Updated: 2026-09-14T13:38:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161056

Initial FDA Quality Management System Regulation (QMSR) investigations have shown that agency investigators are likely to verify that connections between complaint handling, unique device identifier assignment and documentation, and post-market surveillance activities are adequately addressed. An online *Quality Magazine* [article](https://www.qualitymag.com/articles/print/99549-from-qsr-to-qmsr-what-medical-device-manufacturers-need-to-changeand-what-they-dont?ref=fdaweb.com) says dual compliance is also an inspection focus area, with investigators expecting records and labeling to comply with both ISO and FDA requirements.

“The regulatory language requiring that manufacturers ‘undertake to apply’ their procedures will be taken seriously by investigators, who will look for objective evidence that procedures are being followed, such as meeting minutes, reports, or other documentation,” the article says. “Investigators will also ask pointed questions about how companies monitor harmonized standards and common specifications, assessing their impact and documenting decisions. Processes must be demonstrated in action, with recent examples to guarantee approval. The QMSR’s emphasis is on continually improving and maintaining systems ‘in the most effective manner,’ so investigators will examine evidence of the data-driven improvements, such as KPIs (key performance indicators), management reviews, corrective and preventive action effectiveness checks, and metric-driven decisions,” the article says.

Manufacturers who operate globally have a chance, the author says, to simplify and synthesize systems, rather than duplicate them. Successful players will implement ISO 13485 as their foundation, the article says, and then clearly identify FDA-specific additions, using procedure scope statements and traceability matrices to clarify which requirements apply to which markets.

The post says the new QMSR represents the most significant shift in FDA quality system compliance in over 25 years. “With ISO 13485:2016 becoming federal law through incorporation by reference earlier this year, the medical device industry is now liable for following standards which were previously voluntary,” it says.

The story cautions that many companies have mistakenly understood that risk management was a one-time activity during product development, whereas it is now an action to be integrated throughout the entire device lifecycle.