Quality Control
It is the policy of 3D Medical Manufacturing to manufacture only products of QUALITY that will earn customer satisfaction by performing expected functions of design and reliability in accordance with customer expectations.
Our facility is fully GMP compliant and certified to: ISO 9001:2008 and 13485:2003. All device master records are kept on file for the life of the product.
3D’s superior level of quality is based on a corporate Standard of Excellence. Our entire organization is committed to executing this high level of accuracy and quality. We go beyond product satisfaction and strive to form a total business and personal relationship with our customers.
All equipment used in our manufacturing processes including those designated as "Special Processes", have been validated to both the FDA and ISO requirements. We have invested in state-of-the-art inspection equipment, gauging, and experienced personnel to produce exceptional products and services.
QC process improvement Services:
• Special process validation
• Capability Studies
• Process failure mode & effects analysis (PFEMA)
• Gage R & R studies
• SPC Data
• Value engineering to reduce manufacturing cost
• Design support & prototyping
• Dock to Stock shipping
• Supplier Managed Inventory (SMI)
• Kanban programs