The Stratasys Direct manufacturing facility in Tuscon, Arizona has achieved ISO 13485 certification, a globally recognised normal for high quality administration methods in medical gadget manufacturing.
Stratasys can also be set to increase this certification to its different Stratasys Direct manufacturing amenities in Texas and Minnesota.
By attaining ISO 13485 certification, Stratasys Direct is formally recognised for its security, precision, and reliability of its 3D-printed elements. This certification addresses vital regulatory necessities, eradicating boundaries to adoption and enabling medical gadget producers to scale manufacturing reliably whereas accelerating innovation, lowering prices, and bettering affected person outcomes.
Stratasys Direct 3D prints a number of elements for the medical trade making complicated geometries and patient-specific elements that conventional strategies can not obtain.
“ISO 13485 certification is a game-changer for medical manufacturing,” stated Gurvinder Kahlon, Common Supervisor and Vice President, Stratasys Direct. “This achievement displays our dedication to delivering options that not solely meet rigorous regulatory requirements but additionally empower the medical trade to innovate sooner and ship higher affected person care.”
Stratasys Direct has served the medical discipline for years, delivering customized 3D-printed fashions and elements. The ISO 13485 certification builds on that service, offering a transparent pathway to regulatory compliance, making certain constant high quality and increasing market entry for these superior manufacturing options.
In 2023, Stratasys bought one among its Stratasys Direct amenities to Cumberland Additive.
