Quality Assurance for Implant Manufacturing
Tangible Solutions manufactures quality parts utilizing Additive technology while maintaining an aggressive attitude towards continuous improvement, customer service and meeting applicable customer and regulatory requirements. Tangible Solutions is committed to maintaining the effectiveness of its 3D medical implant quality services.
Certification
Tangible Solution’s quality system is certified to ISO 13485:2016 to ensure effective quality system processes. The organization has been certified since 2017 by Eagle Registrations, Inc., and is committed to maintaining the effectiveness of its quality management system.
Capabilities
Tangible Solutions has a wide range of inspection equipment to verify the quality of product, including a Keyence vision system and optical comparator. Tangible Solutions is equipped to inspect and verify the dimensional conformance of medical devices.
Strategy
Tangible Solutions is committed to ensuring the quality of products manufactured utilizing additive technology. Additive manufacturing requires unique quality solutions inherent to the process. All metallic powder is routinely checked to verify that each job meets ASTM F3001 requirements for material properties. Every job is traceable to a mechanical compression coupon to verify that mechanical properties meet specification. All jobs receive in-process inspection, final inspection and a final DHR audit. Tangible Solutions records all inspection results in a dedicated quality system database to allow for trending, statistical analysis and statistical process control (SPC).
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Get StartedWhy Tangible Solutions
Professional Experience
Breadth of knowledge is gleaned from producing over one million orthopedic implants.
Industry Leader
Tangible Solutions has unparalleled expertise as a globally recognized contract manufacturer of American-made 3D printed titanium orthopedic implants.
Prototype to Monthly Orders
Continuous technological improvements driving innovation for developing powerful new medical devices quickly and cost effectively.
Technology Driven
Tangible engineering vision is mathematically driven, wielding the highly advanced power of nTopology, next-generation design software.
