Stratasys Direct Achieves ISO 13485 Certification for Medical Manufacturing

Author

Slice of Manufacturing Team
February 06, 2025

Key Highlights:

  • Stratasys Direct’s Tucson facility achieves ISO 13485 certification, a global standard for medical device manufacturing.

  • Certification ensures safety, precision, and reliability in 3D-printed medical components.

  • Plans to expand certification to Texas and Minnesota facilities.

  • Accelerates medical innovation by enabling regulatory-compliant, cost-effective 3D printing.

  • Stratasys Direct to showcase capabilities at MD&M West, February 4-6, 2025.

Source: Business Wire

Notable Quote:

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"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."

Gurvinder Kahlon, General Manager and Vice President at Stratasys Direct

Why This Matters:

Stratasys Direct’s ISO 13485 certification marks a major milestone in the adoption of 3D printing for medical device manufacturing. The certification removes regulatory barriers, enabling scalable, high-precision, and cost-effective production of medical components. With plans to expand certification across more facilities, Stratasys is positioning 3D printing as a critical tool for the future of healthcare innovation. Medical manufacturers now have a trusted, compliant partner to accelerate product development, enhance patient-specific solutions, and ensure regulatory compliance in a rapidly evolving industry.