Assorted 3D printed medical device prototype components, including black medical device housings and translucent blue and orange parts, arranged on a white tabletop for evaluation.

Support OEM Programs with Certified Medical Components

Reliable, ISO 13485 components for OEM quality and traceability.

ISO 9001 · ISO 13485 · AS9100 · ITAR Registered · Secure & Compliant

ISO 13485 Certified

Meeting strict safety and traceability standards for medical devices.

Medical Materials

PC-ISO, LOCTITE® MED413, TissueMatrix®, and more medical-grade choices.

Parts Printed

6+ Million medical 3D printed parts produced

Full-Service

25+ post process production finishing and inspection services

Tiered suppliers to major medical OEMs must balance cost, speed, and quality while meeting demanding customer requirements. Stratasys Direct supports your production goals with ISO 13485-certified additive manufacturing — ideal for bridge production, jigs and fixtures, or end-use components that need to move fast without sacrificing traceability or performance. Our in-house expertise helps you deliver on time, maintain compliance alignment, and strengthen OEM partnerships.

Engineer sitting in a lab beside a tray of tiered medical device prototypes, holding one prototype in his hands, with a Stratasys 3D printer and other lab equipment in the background.

Challenges in Early-Stage Medical Device Development

Limited funding and resources make it difficult to iterate quickly or access specialized manufacturing capabilities.
Proving functional performance requires production-quality prototypes that inspire investor and partner confidence.
Transitioning from concept to validation introduces design, material, and manufacturability hurdles that slow momentum.

Close-up of a hand holding a small medical device prototype with white housing and blue grip features, showing its refined production-ready design.

Solutions for Early-Stage Medical Device Development

Accelerated medical device prototyping with ISO 13485-certified 3D printing to help you move from concept to validation faster.
Production-grade materials and precision builds that demonstrate real-world function for investors and partners through design validation support.
Collaborative engineering to refine designs for manufacturability and scale — from prototype through pilot production — while staying on budget and schedule.

Talk to an Expert

Technician in cleanroom attire operating quality-control equipment on a production line, inspecting rows of assembled medical device components beneath an automated measurement system.

Why Tiered Suppliers Trust Stratasys Direct® for Medical Production Support

ISO 13485-certified additive manufacturing aligns with OEM quality and documentation requirements.
U.S.-based, in-house production provides consistent turnaround and eliminates third-party supply risk.
Detailed inspection and process documentation support validation and traceability across every build.
Experience with OEM-partnered programs ensures alignment with production standards and communication needs.
Proven reliability and confidentiality strengthen your reputation and relationships with OEM clients.

Ready to Strengthen Your OEM Partnerships?

Meeting tight delivery schedules and maintaining documentation accuracy are critical to keeping OEM programs on track. Stratasys Direct provides ISO 13485-certified additive manufacturing with full traceability, in-house inspection, and rapid turnaround — helping you deliver consistent quality, reduce supply risk, and build lasting customer trust.

Work With An Expert

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