What SME Manufacturers Need to Know—and How QNET Can Support You
The U.S. Food and Drug Administration (FDA) finalized its Quality Management System Regulation (QMSR), marking the most significant overhaul of U.S. medical device quality system requirements in over two decades. The new regulation formally integrates ISO 13485:2016 into 21 CFR Part 820, aligning U.S. expectations with the internationally recognized standard already used in the EU, UK, Canada, and many other jurisdictions.
While this alignment has been widely anticipated, its practical implications for SME manufacturers are substantial.
From Awareness to Execution
Most SME medtech companies are already working with ISO 13485:2016 in some form. However, “ISO-certified” is no longer enough. The QMSR includes FDA-specific expectations that go beyond ISO 13485, such as:
- Documentation and control of complaint handling, corrections, and removals
- Enhanced requirements for software validation used in the QMS and production
- Clear expectations for labeling, packaging controls, and traceability
- Ongoing oversight and documentation for outsourced processes (aligned with 4.1.5 and 7.4)
For many organizations, QMS documents must be revised, roles clarified, and evidence of effective implementation created and maintained—without fragmenting your QMS across regions.
This is not just a regulatory exercise. The QMSR transition presents a strategic opportunity for SMEs to strengthen quality operations, improve internal coherence, and ensure regulatory agility across markets.
Why Partner with QNET?
At QNET, we understand the challenges SMEs face when navigating complex, multi-jurisdictional compliance environments with limited internal resources. We are not a generalist consultancy—we are a specialized regulatory partner offering high-level support that is practical, proportionate, and audit-ready.
Our team brings deep expertise in:
- ISO 13485:2016 implementation and remediation
- FDA QMSR interpretation and integration with MDR/IVDR, UK MDR, and Swissmedic requirements
- Supplier qualification, internal audits, PRRC responsibilities, and post-market surveillance
Whether you manufacture Class I products, operate as a virtual manufacturer, or rely on contract partners for key processes, we help you:
- Conduct a gap analysis between your current QMS and the full scope of QMSR + ISO 13485 requirements
- Develop or update compliant procedures (CAPA, complaint handling, document control, software validation, etc.)
- Prepare for FDA inspections or MDSAP audits
- Optimize your QMS for global market efficiency
Your Next Step: Clarity, Compliance, and Confidence
The transition timeline has begun—and your QMS will come under scrutiny sooner than you think. Don’t wait until notified body or FDA inspections reveal gaps that could delay market access or put your company at risk.
Now is the time to:
- Validate whether your QMS fully meets QMSR expectations
- Identify necessary updates
- Ensure your documentation, processes, and records are robust, aligned, and inspection-ready
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We’ll help you take action with confidence.
QNET – Supporting Regulatory Compliance and Market Access for MedTech Innovators
EU Authorized Representative | UK Responsible Person | Swiss CH-REP | US Agent | ISO 13485 & QMSR Experts