Preparing for FDA Inspection – QSR-Based Quality Systems for Rollator Manufacturers

To sell legally in the U.S., medical device makers like RELAXSMITH ROLLATOR must maintain a robust quality management system compliant with FDA’s 21 CFR Part 820—known as the Quality System Regulation (QSR). This article outlines how to design and sustain an FDA-audit-ready factory operation.

1. What is QSR?

• Legal Framework: QSR defines minimum standards for manufacturing, packaging, labeling, and storage of medical devices.
• Scope: Applies to both Class I (non-exempt) and Class II/III devices; even Class I exempt rollators must comply with select QSR elements.

2. RELAXSMITH ROLLATOR’s Dual-System Approach

• ISO 13485 Backbone: The brand’s factory uses ISO 13485 as a foundation, harmonized with U.S. QSR to avoid duplication.
• Document Control: All SOPs, batch records, and test protocols are version-controlled and archived digitally.
• Design Controls: Used for powered and smart rollator models, documenting verification/validation per QSR Subpart C.

3. FDA Inspection Triggers and Focus Areas

• Initial Entry: FDA often inspects new exporters within 12-18 months of listing.
• Complaint Handling: Complaint logs must show timely investigation, root cause, and corrective action.
• CAPA System: Corrective and Preventive Action files must show issue resolution and systemic improvements.
• Training Records: Staff qualification records are reviewed to confirm role-based training.

4. Factory Readiness Checklist

• Organize all documents into QSR sections: Design, Production, CAPA, Training, Management Review
• Prepare a bilingual (EN+CN) audit response team trained on QSR terminology
• Store digital records in audit-ready format with signature logs

5. Mock Audit Success Tips

• External Review: RELAXSMITH ROLLATOR conducts annual audits using U.S.-based consultants
• CAPA Trace: Use real customer complaint examples to show risk reduction
• Team Readiness: Cross-functional staff attend mock inspections to rehearse responses