Need summary description.
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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. She has over 15 years of Quality experience in the medical device, pharmaceutical, and biologics industries - ensuring operational compliance, implementing quality systems, and leading audit engagements & inspections.
In her role as Director of Quality, Pamela oversees the development of our Quality program and the implementation of policies and procedures that will ensure our continued compliance.