Quality Management Systems
Quality Excellence
We support manufacturers, legal manufacturers, subcontractors, and distributors in building, optimizing, and maintaining world-class Quality Management Systems. Our expertise covers international standards and regulations, ensuring your products remain compliant, safe, and competitive across global markets
Our Services
Quality Management System Development
Design, implementation, and improvement of QMS aligned with:ISO 9001 — general quality managementISO 13485 — medical devicesFDA QSR / 21 CFR Part 820Canada MDSAP / CMDRANVISA (Brazil)NMPA (China)PMDA (Japan)Other country-specific requirements
Gap Assessment & Compliance Roadmap
Comprehensive audits to evaluate your current quality system, identify non-conformities, and establish a clear action plan for full compliance.
Technical Documentation Support
Assistance in creating, updating, and maintaining all QMS documentation including:Quality manual, SOPs and work instructions, Forms and templates, Risk management documentation (ISO 14971), Process validation files
Supplier & Subcontractor Management
Qualification, monitoring, and performance evaluation of suppliers and partners to ensure full compliance throughout your supply chain.
Internal & External Audit Preparation
Audit readiness programs for:Certification bodiesFDA inspectionsMDSAP auditsCustomer and partner audits We prepare your teams and accompany you during the audit.
Post-Market Quality Support
Support for systems related to:Vigilance and reportingComplaint handlingCAPA programsChange controlCustomer feedback management
