As the FDA prepares to implement the long-anticipated Quality Management System Regulation (QMSR)—set to take effect in February 2026—medical device and combination product manufacturers are seeing a noticeable uptick in enforcement tied to inadequate quality systems. The upcoming shift, which harmonizes FDA requirements with ISO 13485:2016, is driving the agency to evaluate whether firms are prepared for a more globally aligned and documentation-intensive framework.
A growing number of recent Form 483s and warning letters have highlighted concerns involving risk management, design controls, supplier qualification, and CAPA effectiveness. These enforcement trends suggest that FDA is using the transition period not only to educate industry, but also to push manufacturers toward compliance expectations that more closely reflect the incoming QMSR standards.
Why FDA Is Increasing Its Focus Now
The QMSR represents the first major overhaul of medical device quality system requirements in decades. Once in effect, manufacturers will be expected to demonstrate tighter integration between:
- Risk management and design controls
- Supplier oversight and purchasing controls
- Documentation traceability
- CAPA evaluation and verification
- Production and process validation
FDA has indicated in public statements and rulemaking summaries that the shift toward ISO 13485 alignment will improve inspection consistency, reduce redundancy for global manufacturers, and strengthen device safety across the supply chain.
At the same time, the agency has stressed that current Part 820 requirements remain fully enforceable until the QMSR’s effective date—which means today’s inspection findings often reflect areas where FDA expects companies to struggle if they do not make updates soon.
Where Manufacturers Are Falling Short
Across 2024–2025 inspection data, several themes have emerged:
1. Insufficient Risk Management Documentation
FDA continues to cite firms for failing to document risk analysis, mitigation effectiveness, or postmarket feedback integration—key principles that ISO 13485 formalizes.
2. Weak Supplier Controls
As global supply chains become more complex, FDA has emphasized supplier evaluation, monitoring, and re-qualification. Many firms still lack documented criteria or performance metrics.
3. CAPA Systems Not Supported by Data
Root cause analyses that rely on assumption rather than evidence are a recurring issue. Under QMSR, CAPA documentation must be more robust and tied to objective risk assessments.
4. Incomplete Design History Files (DHF)
Missing verification/validation evidence, inadequate protocol justification, and incomplete change documentation continue to be high-frequency citations.
5. Poor Integration of Postmarket Data
FDA expects firms to show how complaint trends, MDRs, and service reports tie into their risk management file—a requirement that aligns directly with ISO 13485.
What This Means for Industry
Manufacturers who wait until late 2025 or 2026 to update their systems may face significant operational and regulatory disruption. FDA has made clear through recent enforcement that companies should already be aligning with QMSR principles, even if the rule is not yet in effect.
Organizations with strong, data-driven quality systems will be well-positioned. Organizations with siloed functions, inconsistent documentation, or legacy processes may face:
- Longer inspections
- Greater likelihood of 483s or warning letters
- Delays in premarket submissions
- Increased scrutiny of supplier and risk management processes
How EMMA International Supports Compliance During the Transition
EMMA International has been guiding clients through large-scale quality system modernization projects for over a decade. Our experts help manufacturers:
- Conduct QMS gap assessments against both Part 820 and ISO 13485
- Build or upgrade risk management files aligned with ISO 14971
- Strengthen supplier controls, approval criteria, and quality agreements
- Develop or remediate CAPA systems to meet data-driven expectations
- Prepare for FDA inspections and navigate post-inspection enforcement
- Modernize documentation and integrate QMS elements across global sites
With QMSR approaching, early preparation is the most effective way to minimize compliance risk and operational burden.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. (2024). Proposed rule: Medical Devices; Quality Management System Regulation. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2025). Inspectional Observation Data. Center for Devices and Radiological Health.
International Organization for Standardization. (2016). ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes. ISO.
