Integrated quality management system ensuring ISO 13485 and IEC safety standard compliance across all product manufacturing and operations. Supports comprehensive regulatory documentation and traceability.
Manufactured by
Sterile Safequip USA LLC
Schaumburg, IL, United States
SSQLLC offer an IVD products that is designed to meet the specific needs of our clients. Our products are equipped with advanced technology, state of the art facilities that ensures efficient and effective sterilization. Our products are available in a variety of sizes. We also provide customized solutions. At our stall you have seen our latest Innovation in Coagulation meter; ESR and Semi automatic and automatic Chemistry analyzer. Please visit our site www.ssqllc.com for more information.
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Helio Diagnostics · France
Integration and support of quality management systems for ISO 13485 compliance and FDA 21 CFR Part 820 requirements. Includes audit preparation, documentation systems, and regulatory compliance frameworks.
PTC (Parametric Technology UK Ltd) · United Kingdom
Cloud-native Quality Management System (QMS) platform designed for medical device and healthcare product development. Integrates product lifecycle management with quality control processes, enabling seamless collaboration between design and quality teams while maintaining regulatory compliance. Connects quality records with product designs in a unified system to accelerate product launches and meet healthcare compliance standards.
QMS Wrapper Ltd. · Canada
AI-powered QMS platform designed to automate quality management and regulatory compliance for medical device manufacturers. Streamlines change impact analysis, technical file traceability, CAPA management, and audit readiness across FDA QMSR and EU MDR requirements. Guides organizations from paper-based processes into connected ISO 13485 workflows with event-to-evidence intelligence.
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