For nearly 30 years, the medical device industry has relied on the QSR (21 CFR Part 820). On February 2, 2026, that era ends.
The FDA’s transition to the Quality Management System Regulation (QMSR)—harmonizing with ISO 13485:2016—isn’t just a “paperwork update.” It is a fundamental shift in how the FDA expects you to manage risk, oversee suppliers, and document every stage of the product lifecycle.
If your suppliers are still operating on legacy QSR checklists, your 2026 market access is already at risk.
The Kent Group: Audit Integrity in the QMSR Era
In this new regulatory landscape, a “generic” GMP audit is a liability. Now you will need auditors who understand that the FDA now expects risk-based decision-making to permeate every layer of your supply chain.
Why The Kent Group stands out from the competition:
- Forensic Risk Integration: While other firms simply check for a “Risk Management File,” we audit the effectiveness of the risk controls. We trace risk from design inputs through to supplier manufacturing processes, ensuring no gaps exist for FDA inspectors to find.
- MDF (Medical Device File) Specialists: We don’t just look for old DHF/DHR records. We ensure your suppliers have successfully transitioned to the Medical Device File structure required under ISO 13485 and QMSR.
- Regulatory Translators: Our auditors are experts in the “FDA-specific supplements.” We ensure your global suppliers meet the unique U.S. requirements for Labeling, UDI, and MDR reporting that ISO 13485 alone does not cover.
- Ground Truth Verification: We don’t take a supplier’s word for it. We provide “boots-on-the-ground” verification to ensure their internal “QMSR Transition Plan” is a reality, not just a document stored in a folder.
Is Your Supply Chain Ready?
Under the QMSR framework, the FDA has clarified that they will have increased scrutiny over outsourced activities. Your suppliers’ failures are now, more than ever, your failures in the eyes of the agency.
Don’t Wait for a Form 483 to Find the Gaps. The clock is ticking toward February 2026. Secure your market access by partnering with an audit firm that provides more than a checklist—we provide the Ground Truth.
The Kent Group is currently booking QMSR Gap Analysis Audits for the remainder of 2025 and early 2026.
Contact us to schedule your Supply Chain Readiness Audit. Contact us nationwide to discuss how we can de-risk your QMSR transition.
THE KENT GROUP ASSOCIATES
2 Industrial Rd Suite 203 Fairfield, NJ 07004
Ph: 973-402-5889
contact@thekentgroup.com
www.thekentgroup.com
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