FDA QMSR / MDSAP Quality System

What This Service Covers

Alignment of quality systems with FDA QMSR requirements
Transition support from legacy FDA QSR (21 CFR 820) to QMSR
MDSAP-ready quality system design and integration
Jurisdiction-specific requirement mapping within a single QMS
Inspection and audit readiness for FDA and MDSAP audits
System-level remediation following regulatory observations

When This Service Is Typically Required

Transitioning from FDA QSR to FDA QMSR
Preparing for FDA inspections or MDSAP audits
Expanding into multiple regulated markets under MDSAP
Addressing FDA 483 observations or systemic QMS gaps
Harmonizing ISO 13485 systems with FDA and MDSAP expectations

Applicable Regulations & Standards

FDA QMSR
21 CFR Part 820 (legacy QSR, transition context)
ISO 13485
MDSAP Audit Model
Applicable jurisdictional regulations (FDA, Health Canada, TGA, ANVISA, PMDA)

How This Fits Within the Quality System

This service ensures the quality management system meets FDA and MDSAP regulatory expectations through system-level controls, not parallel or duplicate processes.

FDA and MDSAP requirements are embedded into core QMS processes, enabling consistent compliance across markets and sustained inspection readiness.

Contact

Discuss your FDA QMSR or MDSAP quality system requirements with us to define a scope aligned to your regulatory objectives.