Devices

Complying with QMSR ‘Critical Business Strategy’: Attorneys

David McFarland

— 1 min read
Share

Three Alston & Bird attorneys say that complying with FDA’s forthcoming Quality Management System Regulation (QMSR) is not just a regulatory obligation but a critical business strategy. Writing in a detailed Drug & Device Advisory, the attorneys discuss FDA’s 10/27 draft guidance describing the Quality Management System information it expects in PMA and HDE submissions under QMSR, which becomes effective 2/2/2026. They note that QMSR will apply to all medical devices, replacing the legacy Quality System regulation, but the agency has not yet issued guidance on QMSR expectations for 510(k) and de novo submissions.

QMSR signals the agency’s transition from a U.S.-centric regulation to a globally harmonized, risk-based system aligned with ISO 13485, the post says. While the basic submission format remains familiar, it says, FDA now recommends additional elements such as DUNS numbers (issued by Dun & Bradstreet) for all manufacturing sites, a plan for unique device identification system assignment and maintenance, a dedicated QMSR module for modular PMAs, and mapping of QMS content directly to ISO 13485 clauses.

The attorneys say that to prepare for QMSR implementation, companies should conduct a gap analysis comparing their existing QS-based systems to the ISO 13485-aligned framework. “Given the breadth of the new requirements,” they say, “broader collaboration among relevant teams and external partners will be crucial. Regular cross-functional meetings, centralized document management, and strong internal communication will help maintain consistency and readiness across departments.” They suggest:

  • Quality and Manufacturing should lead updates to procedures, risk rationales, and validation documentation;
  • Regulatory Affairs should ensure alignment with submission structure and evolving FDA expectations;
  • Research and Development should verify that controls, risk management, and verification/validation activities meet ISO 13485 principles;
  • Clinical Affairs and Post-Market Surveillance should ensure that complaint handling aligns with MDR processes and that production/postproduction feedback is integrated into risk management;
  • Supply Chain and Procurement should evaluate supplier qualification, monitoring processes, and documentation under the new risk-based requirements; and
  • Information Technology and Document Control can help ensure traceability, version control, and electronic document readiness for inspection and submission.

The attorneys encourage medical device manufacturers to begin QMSR transition planning without delay. “By identifying gaps early, clearly documenting risk-based rationales, and fostering structured collaboration among internal teams and external partners,” they write, “your organization will be well-positioned for successful submissions and inspections under the new QMSR framework by 2/2026.”

Read more