Stratasys Direct Achieves ISO 13485 Certification, Advancing 3D Printing for Medical Manufacturing!

Stratasys Direct, a leading provider of additive manufacturing (AM) solutions, has achieved ISO 13485 certification for its Tucson, Arizona facility. This globally recognized quality management standard for medical device manufacturing strengthens regulatory compliance, accelerates innovation, and enables scalable, cost-effective production for the medical and dental industries.

Gurvinder Kahlon, General Manager and Vice President of Stratasys Direct, emphasized the importance of this certification, stating:
“ISO 13485 certification is a game-changer for medical manufacturing. This achievement reflects our commitment to delivering solutions that not only meet rigorous regulatory standards but also empower the medical industry to innovate faster and deliver better patient care.”

With ISO 13485 compliance, medical device manufacturers can now leverage Stratasys Direct’s additive manufacturing capabilities to:
✔ Reduce development timelines by eliminating tooling constraints.
✔ Create highly customized components, improving patient-specific solutions.
✔ Ensure regulatory compliance, streamlining approval processes.
✔ Scale production reliably, while maintaining consistent quality standards.

By adopting 3D printing, medical manufacturers can overcome traditional production barriers, enabling:
📌 Faster prototyping and iteration, allowing for rapid design adjustments.
📌 On-demand manufacturing, reducing inventory costs and waste.
📌 Complex geometries and biocompatible materials, enhancing surgical tools, implants, and prosthetics.

With this milestone certification, Stratasys Direct is paving the way for the future of medical device manufacturing, enhancing patient outcomes through advanced additive solutions.

This achievement marks a new era of precision, efficiency, and compliance in 3D-printed medical innovations. Stay tuned for more breakthroughs in healthcare manufacturing!