3d Medical Manufacturing

Quality Systems

It is the quality policy of 3D Medical Manufacturing to produce products that fully meet customer expectations through compliance to customer engineering drawings and technical specifications.

3D Medical’s facility is ISO 13485:2003 and ISO 9001:2008 certified by an MDD validated registrar.   3D is fully compliant to FDA 21CFR part 820 and our company practices cGMP and cGDP.  All device history 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”, has been validated to both the FDA and ISO requirements. 3D Medical’s invests in state-of-the-art inspection equipment, gauging, and experienced personnel to produce exceptional products and services.

In-House Support Services

  • 100% IQ / OQ validated Manufacturing Equipment
  • IQ / OQ / PQ validated Special Process Equipment
  • Full and / or partial  Product Part Approval Process [PPAP] (available)
  • Capability Studies with Minitab 6 packs (available)
  • Process failure mode & effects analysis [PFMEA] (available)
  • Gage R & R studies (available)
  • SPC Data (available)
  • Value engineering to reduce inspection cost
  • Dock to Stock shipping

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