Quality and Manufacturing Management

The GlobalMed Logistix Quality Regulatory System is extremely adaptable and provides the GMLx client with multifaceted layers of protection from a regulatory perspective. GMLx’s quality and regulatory services include but are not limited to: Initial Importer, Repackage Relabeler, CAPAs, Recall Coordinator, Field Corrections, Product Complaint Handling, MDRs, Inventory Traceability per FDA Regulations, UDI Consulting, and Third Party Customer Audits / FDA / Vendor Verification.

GMLx also provides companies with the opportunity to reduce cost in manufacturing by coordinating, leading, and managing the assessment of the cost of manufacturing relative to their current situation.

GMLx is ISO 13485:2016 certified 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.

Service Offerings

  • Initial Importer
  • FDA Registration
  • FDA Agent
  • Quality Management System
  • Repackaging