Stratasys' Arizona Factory Earns ISO Certification for Medical Device Manufacturing

The company plans to extend this certification to its Direct facilities in Texas and Minnesota.

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Stratasys

Stratasys today announced that its Stratasys Direct manufacturing facility in Tuscon, Arizona has achieved ISO 13485 certification, a globally recognized standard for quality management systems in medical device manufacturing. Stratasys plans to extend this certification to its other Stratasys Direct manufacturing facilities in Texas and Minnesota.

By achieving ISO 13485 certification, Stratasys Direct is formally recognized for its safety, precision, and reliability of its 3D-printed components. This certification addresses critical regulatory requirements, removing barriers to adoption and enabling medical device manufacturers to scale production reliably while accelerating innovation, reducing costs, and improving patient outcomes.

Stratasys Direct 3D prints multiple components for the medical industry making complex geometries and patient-specific components that traditional methods cannot achieve.

Stratasys Direct has been a trusted partner to the medical field for years, delivering custom 3D-printed models and components. The ISO 13485 certification builds on that legacy, positioning 3D printing as an essential tool for the medical device industry. By adopting 3D printing, medical manufacturers can reduce development times, create highly customized components, and innovate faster than with traditional manufacturing methods. Stratasys Direct’s ISO 13485 certification provides a clear pathway to regulatory compliance, ensuring consistent quality and expanding market access for these advanced manufacturing solutions.

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