Need summary description.
GMLx is a FDA registered Initial Importer and US Agent. We also perform incoming and outgoing AQL inspections, repackage and relabeling services, instrument tray inspection, instrument functional testing and tracking and trending of non-conformances.
Quality Management
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Initial Importer
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FDA Registration
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QMS
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FDA Agent
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Repackaging
What We Provide
The GlobalMed Logistix Quality Management System is extremely adaptable and provides the GMLx client with multifaceted layers of protection from a regulatory perspective. GMLx’s quality services include but are not limited to: QMS Management & Audit Support, Initial Importer, U.S Agent Repackaging, Product Complaint Handling, and Inventory Traceability.
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GMLx holds a current ISO 13485:2016 certification and adheres to the regulations mandated by the FDA for all operational, inventory management and storage functions. The GMLx Quality Management System is designed to comply with the applicable parts of ISO 13485, 21 CFR Part 820 Quality System Requirements, 803 (Medical Device Report & MDR), 806 (Corrections and Recalls), 807 (Establishment Registration) and other regulatory and statutory requirements.
Quality Management Services:
QMS Management & Audit Support
Initial Importer
U.S. Agent
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Meet our Quality Leadership
Pamela McColl
Pamela joined the GlobalMed Logistix leadership team in 2021, bringing over 15 years of advanced Quality experience across the medical device, pharmaceutical, and biologics industries. She has led Quality operations from product inception through full-scale manufacturing, distribution, and post-market activities, giving her a comprehensive understanding of the full product lifecycle and regulatory landscape.
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Her background includes overseeing end-to-end medical device manufacturing for multiple companies, including design transfer, supplier quality, production oversight, labeling, sterilization, distribution, and complaint handling. This breadth of experience has made her highly effective at building and scaling ISO 13485- and FDA-compliant quality systems that meet both regulatory requirements and business goals.
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As Director of Quality, Tissue Director, Pamela leads the development and continuous improvement of the GMLx Quality Management System. She oversees all quality system activities, with a strong focus on regulatory alignment, risk-based decision-making, and customer satisfaction.
Pamela also manages the Quality Control department, which performs AQL-based product inspections, as well as repackaging and relabeling services in accordance with FDA labeling regulations. Her team supports medical device manufacturers by ensuring product compliance through validated processes and robust quality controls.
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Prior to joining GMLx, Pamela worked for a tissue processor and accredited tissue bank, where she gained extensive experience with the handling, regulatory compliance, and auditing of human tissue. She has applied that expertise at GMLx to support the storage and quality oversight of both ambient and cold chain human tissue products, ensuring compliance with FDA and industry standards.
Her deep operational knowledge, cross-functional leadership, and audit readiness expertise make her a key driver of GMLx’s quality-focused culture and a trusted quality partner across the industry.
Director of Quality, Tissue Director
