A sleek white handheld medical device with digital buttons and a display, shown on a clean surface in a bright clinical lab setting.

Accelerate Medical Device Prototyping — Without Compromising Compliance

Supporting validation, full-scale production, and replacement component needs for the world’s leading medical device manufacturers.

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

ISO 13485 Certified

Meeting strict safety and traceability standards for medical devices.

Medical Materials

ABS-M30i, Somos® BioClear, MED615RGD™, and more medical-grade choices

Parts Printed

6+ Million medical 3D printed parts produced

Full-Service

25+ post process production finishing and inspection services

Large OEMs face constant pressure to bring medical devices to market faster while navigating strict ISO 13485 manufacturing and FDA requirements. Stratasys Direct enables you to accelerate prototyping cycles with certified 3D printing — ensuring rapid turnaround, complete traceability, and confidence in regulated device development.

Engineers in a lab review detailed technical drawings and CAD models for a medical device on dual computer monitors, surrounded by electronic equipment and prototype components.

Challenges in Medical Device Prototyping and Compliance

Lengthy prototyping cycles slow down device programs and increase costs.
Maintaining design history files and traceability across every prototype iteration is complex and resource-intensive for medical device component manufacturers.
Design changes ripple through multiple components, causing delays and rework.

Two engineers in lab coats review a 3D CAD model of a medical device on a computer monitor while one of them holds a 3D printed prototype.

Solutions for Medical Device Prototyping and Compliance

Accelerated prototyping cycles with ISO 13485-certified 3D printing — reducing iteration times without compliance trade-offs.
Integrated documentation and inspection for full Design History File (DHF) traceability.
Expert engineering support to anticipate design complexities and prevent costly delays or rework.

Talk to an Expert

Engineer in a lab coat holding a white 3D printed medical device prototype while standing in a clean, modern medical manufacturing lab.

Why Large OEMs Trust Stratasys Direct^® for Medical Device Prototyping

ISO 13485-certified facilities to ensure compliance in regulated device development.
200+ in-house printers and U.S. facilities to deliver scale without outsourcing risk.
Multi-stage inspection and documentation supporting Design History File (DHF) requirements.
30+ years of additive experience partnering with leading medical device manufacturers.
Secure, in-house production that protects sensitive device designs.

Ready to Accelerate Your Device Prototyping?

Bringing a medical device to market requires speed, compliance, and confidence. Stratasys Direct delivers ISO 13485-certified 3D printing services that help OEM teams move from prototype to production with reduced risk and faster timelines — with access to the newest materials and custom R&D support for the toughest medical challenges.

Work with an Expert

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Medical Materials Guide with PolyJet, SLA, MJF, SLS, SAF, P3 DLP, and FDM, plus biocompatibility, specs, certifications, and sterilization data.

Loctite MED 413 White 3D Printed Medical Device

Biocompatible Materials at ISO 13485 Facility

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ISO 13485-Certified 3D Printing for Medical Device Manufacturing

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Medical Materials Guide with PolyJet, SLA, MJF, SLS, SAF, P3 DLP, and FDM, plus biocompatibility, specs, certifications, and sterilization data.

Stratasys Direct is accelerating medical device manufacturing with ISO 13485 certification, innovative biocompatible materials like LOCTITE MED 413 and Somos BioClear, and advanced additive manufacturing solutions for high-performance medical applications.

Stratasys Direct offers ISO 13485-certified 3D printing services, ensuring precision and compliance for medical device manufacturing. From prototyping to scalable production, we streamline the entire development process with cutting-edge additive technology.

Discover biocompatibility and sterilization impact 3D printed medical devices. Learn ISO 10993 testing, sterilization methods, and validated workflows to ensure safety, compliance, and patient-ready additive manufacturing.

See how hospitals improve surgical planning, reduce OR time, and enhance patient communication with 3D models. Real-world impact from UK & Spain case studies.

Accelerate Medical Device Prototyping — Without Compromising Compliance

ISO 13485 Certified

Medical Materials

Parts Printed

Full-Service

Challenges in Medical Device Prototyping and Compliance

Solutions for Medical Device Prototyping and Compliance

Why Large OEMs Trust Stratasys Direct® for Medical Device Prototyping

Ready to Accelerate Your Device Prototyping?

Related Resources

Medical Materials Resource Guide

Biocompatible Materials at ISO 13485 Facility

ISO 13485-Certified 3D Printing for Medical Device Manufacturing

Biocompatibility and Sterilization in 3D Printed Medical Devices

From Scan to Scalpel: The Impact of 3D Printed Models in the Operating Room

Why Large OEMs Trust Stratasys Direct^® for Medical Device Prototyping