Product Overview
Quality Assurance Services - Implementation & Compliance support
SARACA Solutions delivers end-to-end Quality Management System (QMS) services for medical device and software-based medical device manufacturers, supporting compliance with ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR – 21 CFR Part 820). We support the development, implementation, remediation, and maintenance of audit-ready QMS frameworks aligned with U.S. FDA, EU MDR, and global medical device regulatory requirements.
QMS Services Scope:
- ISO 13485 & FDA QMSR QMS development, upgrade, and remediation
- Gap analysis and inspection readiness assessments
- Transition support from legacy 21 CFR Part 820 to FDA QMSR
- Design Controls and DHF implementation and remediation
- Risk Management integration per ISO 14971
- Document control, supplier controls, and CAPA management
- Complaint handling and FDA MDR integration
- Internal audits and management review support
- Support during ISO certification audits and FDA inspections
Help others choose confidently by sharing your feedback.
