The implementation and maintenance of an efficient and effective Quality Management System is the foundation of regulatory compliance around the world.
Whether you’re marketing in a single market or globally, we have the resources and expertise to help you establish and maintain an efficient and effective quality management system that is continuously compliant with all market requirements. Our expert QMS consultants have specialized in QMS implementation and compliance and can provide assistance in any market globally.
Sparko Quality Consulting has extensive experience establishing quality management systems that are compliant with ISO 13485, US FDA 21CFR 820 Quality System Regulation, EU Medical Device Regulation (MDR) / In-Vitro Diagnostic Device Regulation (IVDR), MDSAP, and other global quality system requirements. We can also perform internal quality system and readiness audits.
Sparko Quality Consulting 