FDA-aligned. ISO-certified. Precision-manufactured. We support medical device companies, healthcare providers, and surgical teams with 3D printing, nomenclature marking, and surgical guide production that meets the highest regulatory standards.
From surgical guides to nomenclature-marked device housings — our Minneapolis and Denver facilities are equipped to handle your most demanding medical manufacturing requirements.
From patient-specific surgical guides to nomenclature-marked medical devices — we support every stage of medical manufacturing with precision, documentation, and regulatory alignment.
3D printed surgical guides for orthopedic, dental, and spinal procedures. Custom-fitted to patient anatomy from CT/MRI scans — reducing OR time and improving surgical accuracy.
Accurate anatomical models for pre-surgical planning, surgeon training, and patient education. Printed from patient imaging data in sterilizable or clear materials.
Part numbers, lot codes, serial numbers, FDA-required markings, and branding printed directly on medical device housings, surgical instruments, and packaging — using pad transfer, UV digital, and laser marking.
Functional prototypes for injection-molded medical device housings, drug delivery devices, diagnostic equipment, and surgical instruments — in biocompatible and sterilizable materials.
FDA-cleared dental resins for surgical guides, cast patterns, models, and gingival masks. High-precision SLA printing for crowns, bridges, and aligner models.
Custom-fitted orthotic bracing, prosthetic test sockets, and wearable medical device components. Patient-specific sizing from scans or measurements in biocompatible, skin-safe materials.
Medical manufacturing demands more than precision — it requires documented processes, certified materials, and documented traceability. We understand the regulatory landscape and build compliance into every step.
Our processes are designed to align with FDA QSR (21 CFR Part 820) and ISO 13485 quality management requirements. We maintain detailed documentation for every job.
We work with FDA-cleared and ISO-certified biocompatible resins — including surgical guide, dental, and Class I/II materials. Material data sheets and certificates of conformance available.
Every medical job is tracked by lot number — material batch, machine, operator, and build parameters. Certificates of conformance available on request for every production run.
Medical device designs are among the most sensitive intellectual property. We implement strict file security, NDA protocols, and clean-room-style handling procedures for all medical work.
We stock a range of FDA-cleared and ISO-certified resins and thermoplastics suitable for medical applications. The right material for every use case — from surgical guides to wearable devices.
FDA-cleared, sterilizable resin for patient-specific surgical guides. Steam autoclave and gamma sterilization compatible. Available in opaque and clear.
FDA-cleared resin specifically formulated for dental implant surgical guides. Prints at high resolution for ultra-precise guide holes and钉 alignment.
ISO 10971-certified resin for long-term skin contact and short-term mucosal membrane contact. Suitable for wearable medical devices and orthotic components.
High-accuracy, smooth-surface resin for diagnostic models, study models, and pre-surgical planning replicas. Available in pink, white, and gray tones.
Zero-ash burnout pattern resin for dental crowns, bridges, and custom medical castings. Clean burnout with zero residue for flawless metal and ceramic castings.
Durable SLS nylon in gamma-sterilizable grade for end-use medical components, housings, and functional parts requiring toughness and chemical resistance.
Material selection depends on your specific application and regulatory requirements. Contact us to discuss the right material for your project — with certificates of conformance available for every medical material.
Upload your design files or describe your medical manufacturing requirements. Our team will respond with material recommendations, regulatory considerations, and a detailed quote — typically within one business day.