McFarlane Medical: Regulatory and Quality Services

Partnering Benefits

REGULATORY AND QUALITY SERVICES
ISO 13485:2003 certified, FDA 21CFR, Part 820 Compliant

RA/QA Consultation
RA/QA Support
Purchasing

Design History Record
Production Specifications
Device Master Record
Bill of Material
Device History Records
Technical File Submissions
510k Submissions
Process Validation

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