Medical Device Prototyping & 3D Printing

Custom medical device prototyping in Montreal for healthcare innovators, medtech startups, and hospital R&D departments. We produce biocompatible 3D printed prototypes for surgical guides, implant housings, anatomical models, and diagnostic equipment — from single concept prototypes to small-batch production runs.

🛡ISO 10993 Certified Materials
⏱3–5 Day Turnaround
📋Full Regulatory Documentation

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Medical Device Prototyping & 3D Printing

Our Expertise

Medical Device Prototyping Services

AllPrototype provides end-to-end 3D printing for medical device development — from early-stage concept models to functional prototypes ready for regulatory testing. Whether you’re a medical device startup validating your first design or an established manufacturer iterating on next-generation products, we deliver custom prototypes for medical devices with the precision and biocompatibility your projects demand.

What We Prototype

🩺

Surgical Instruments & Guides

Patient-specific drill guides, cutting jigs, and instrument handles with ±0.1mm accuracy.

❤️

Implant Prototypes

Biocompatible housing prototypes for pacemakers, insulin pumps, hearing aids, wearable monitoring devices.

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Anatomical Models

Full-scale patient-specific models from CT/MRI DICOM data for pre-surgical planning and medical education.

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Diagnostic Device Housings

Functional enclosures for point-of-care testing devices, handheld diagnostics, and lab equipment.

😁

Dental Appliances

Surgical guides, orthodontic models, crown & bridge models with dental-grade SLA resins.

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Custom Lab Equipment

Microfluidic chips, drug delivery device prototypes, and research tools.

How It Works

Our Medical Prototyping Process

A streamlined, quality-controlled workflow from file upload to finished medical-grade part.

1

Design Review (Free)

Send your CAD files or sketches. Our engineers review for printability and recommend materials based on biocompatibility requirements.

2

Material Selection

Choose from biocompatible SLA resins (ISO 10993, USP Class VI) or SLS nylon (PA12 biocompatible) based on your application.

3

Rapid Prototyping

Parts printed in 24–48 hours (rush) or 3–5 business days (standard). Multiple iterations possible within the same week.

4

Quality & Documentation

Dimensional inspection, material certificates, lot traceability, and compliance documentation for regulatory submissions.

Medical Device Prototyping & 3D Printing

Our Advantage

Why Montreal Medical Companies Choose AllPrototype

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Speed

3–5 day standard turnaround. 24-hour rush available for urgent surgical cases.

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Biocompatible Materials

ISO 10993 and USP Class VI certified resins and nylons for safe patient contact.

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Regulatory Support

Documentation packages for FDA 510(k), EU MDR, and Health Canada submissions.

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Local Service

In-person consultations in Montreal, same-day pickup, NDA-protected projects.

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Track Record

200+ medical projects completed for hospitals, dental clinics, medtech startups, and research labs across Quebec.

Proven Results

Medical & Healthcare Success Stories

Real examples of how our medical-grade 3D printing has supported healthcare professionals, medical device companies, and research institutions in advancing patient care.

SLA
Surgical Guide Resin
3-5 days per guide

Custom Surgical Guide for Orthopedic Surgery

Montreal Teaching Hospital

Challenge

Create patient-specific surgical guides for complex hip replacement procedures requiring precise drilling angles and placement accuracy.

Solution

Utilized medical-grade SLA resin to produce sterilizable surgical guides from CT scan data. Guides featured unique anatomical fit for each patient.

Results

✓ Reduced surgery time by 35%
✓ Improved implant positioning accuracy to ±1mm
✓ Successfully sterilized via autoclave
✓ Used in 15+ procedures with 100% success rate
SLA Multi-Material
Standard + Flexible Resin
2-3 days

Anatomical Models for Pre-Surgical Planning

Cardiovascular Surgery Department

Challenge

Produce accurate, full-scale anatomical heart models from patient MRI data for complex congenital heart defect repair planning.

Solution

3D printed multi-material anatomical models showing heart chambers, vessels, and defects. Used flexible and rigid resins to simulate tissue properties.

Results

✓ Enabled surgeons to practice procedure beforehand
✓ Identified 2 potential complications pre-surgery
✓ Reduced operative time by 40 minutes
✓ Improved patient outcome confidence
SLA Dental
Dental SG Resin
24-48 hours

Dental Surgical Guide and Model

Oral Surgery Clinic

Challenge

Create precise dental implant surgical guides and jaw models for multiple patients requiring implant placement.

Solution

Produced biocompatible surgical guides and high-accuracy dental models from intraoral scans using dental-specific SLA resins.

Results

✓ ±25μm accuracy achieved
✓ Guides fit perfectly on first attempt
✓ Reduced chair time by 50%
✓ Process 20+ patients per month
SLS
PA12 Biocompatible
4 weeks total

Medical Device Prototype – Insulin Pump Housing

Medical Device Startup

Challenge

Rapidly iterate on wearable insulin pump housing design requiring biocompatibility, durability, and patient comfort validation.

Solution

Used SLS biocompatible nylon to create functional prototypes for user testing, drop testing, and regulatory submission documentation.

Results

✓ Completed 8 design iterations in 6 weeks
✓ Passed biocompatibility testing (ISO 10993)
✓ User comfort rating improved from 6/10 to 9/10
✓ Secured FDA 510(k) clearance
SLS
PA12 Nylon
5-7 days

Orthotic and Prosthetic Components

Prosthetics Manufacturer

Challenge

Develop custom-fit prosthetic socket components and orthotic braces for individual patients with unique anatomical requirements.

Solution

Combined 3D scanning with SLS printing to create lightweight, strong, and comfortable custom-fit components for each patient.

Results

✓ 40% lighter than traditional methods
✓ Perfect fit on first fabrication
✓ Production time reduced from 3 weeks to 5 days
✓ Patient satisfaction increased significantly
SLA
High Temp + Clear Resin
2-4 days

Pharmaceutical Lab Equipment

Research Laboratory

Challenge

Create custom micro-fluidic devices and lab equipment for drug testing and research applications requiring chemical resistance.

Solution

Utilized high-temp and clear SLA resins to produce precise laboratory equipment with complex internal channels and optical clarity.

Results

✓ ±0.05mm channel accuracy achieved
✓ Chemical resistant to common solvents
✓ Cost 90% less than traditional manufacturing
✓ Enabled rapid experimentation iteration

Certified Materials

Medical-Grade Materials

We use biocompatible, sterilizable, and certified materials specifically approved for medical and healthcare applications, meeting rigorous safety and performance standards.

🛡Sterilizable

Surgical Guide Resin (SLA)

Surgical guides, dental guides, anatomical models for sterilization

Material Properties

SterilizationAutoclave compatible
BiocompatibilityISO 10993, USP Class VI
Accuracy±0.1mm
TransparencyNatural/Clear

Key Features

  • ✓ Gamma and EtO sterilization compatible
  • ✓ Excellent dimensional stability
  • ✓ Biocompatible for short-term contact
  • ✓ Smooth surface finish
ISO 10993USP Class VI
🧪Dental Grade

Dental SG Resin (SLA)

Dental surgical guides, implant planning, orthodontic models

Material Properties

Accuracy±25μm
BiocompatibilityClass IIa Medical Device
SterilizationAll methods compatible
ColorBeige/Natural

Key Features

  • ✓ Exceptional accuracy for dental applications
  • ✓ Certified for intraoral use up to 30 days
  • ✓ Resistant to oral fluids
  • ✓ Easy to clean and sterilize
ISO 10993-1EN ISO 13485MDR Class IIa
💧Biocompatible

BioMed Clear Resin (SLA)

Medical device prototypes, fluid handling, anatomical models

Material Properties

BiocompatibilityISO 10993, USP Class VI
TransparencyClear/Translucent
Tensile Strength50 MPa
Elongation12%

Key Features

  • ✓ Ideal for fluid flow visualization
  • ✓ Long-term skin contact approved
  • ✓ Chemical resistant
  • ✓ Good dimensional stability
ISO 10993USP Class VI
🛡Functional

PA12 Biocompatible (SLS)

Prosthetics, orthotics, medical device housings, wearables

Material Properties

BiocompatibilityISO 10993-5, ISO 10993-10
Tensile Strength48 MPa
Chemical ResistanceExcellent
Density0.95 g/cm³

Key Features

  • ✓ Suitable for skin contact applications
  • ✓ Strong and durable
  • ✓ No support structures required
  • ✓ Good chemical resistance
ISO 10993-5ISO 10993-10FDA contact approved
💧Flexible

Elastic Resin (SLA)

Soft tissue models, wearable prototypes, seals and gaskets

Material Properties

Shore Hardness50A
Elongation160%
Tear StrengthHigh
BiocompatibilityAvailable

Key Features

  • ✓ Rubber-like flexibility
  • ✓ High tear resistance
  • ✓ Excellent compression set
  • ✓ Biocompatible variants available
ISO 10993 (biocompat. variant)
🔥Thermal Resistant

High Temp Resin (SLA)

Sterilizable surgical tools, autoclavable models, thermal testing

Material Properties

HDT @ 0.45 MPa238°C
SterilizationAutoclave compatible
Tensile Strength55 MPa
BiocompatibilityISO 10993

Key Features

  • ✓ Withstands autoclave sterilization
  • ✓ High temperature stability
  • ✓ Excellent precision
  • ✓ Chemical resistant
ISO 10993RoHS compliant

Regulatory Compliance

All medical-grade materials come with full documentation including biocompatibility certificates, material safety data sheets (MSDS), and compliance statements. We maintain traceability for all medical projects and can provide batch-specific documentation as required.

Quality Assurance

Compliance & Quality Standards

We understand the stringent requirements of medical device manufacturing and maintain the highest standards of quality, traceability, and regulatory compliance.

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Biocompatibility Testing

Materials tested per ISO 10993 standards for cytotoxicity, sensitization, and irritation.

Standards & Methods

ISO 10993-5ISO 10993-10USP Class VI
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Quality Management

Production processes follow medical device quality management system requirements.

Standards & Methods

ISO 13485Good Manufacturing Practice
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Material Certification

Full material traceability with batch-specific certificates and data sheets.

Standards & Methods

Material Data SheetsLot TraceabilityCoC
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Sterilization Compatible

Materials validated for various sterilization methods required in healthcare.

Standards & Methods

AutoclaveEtOGamma Radiation
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Documentation

Comprehensive documentation package for regulatory submissions and validation.

Standards & Methods

Test ReportsCertificatesTechnical Data
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FDA & MDR Compliance

Materials and processes aligned with FDA and EU Medical Device Regulation requirements.

Standards & Methods

FDA 510(k) SupportEU MDRHealth Canada

Working with Medical Device Companies

We partner with medical device manufacturers, research institutions, and healthcare facilities throughout the product development lifecycle:

✓ Early Stage Development

Rapid prototyping for concept validation, design iterations, and feasibility studies.

✓ Verification & Validation

Functional prototypes for testing, biocompatibility validation, and performance verification.

✓ Regulatory Submission

Documentation packages, material certificates, and test samples for FDA/MDR submissions.

✓ Clinical & Market Trials

Small batch production for clinical trials, pilot programs, and initial market introduction.

Important Notice: While our materials and processes meet medical device standards, the responsibility for regulatory approval and clinical use remains with the device manufacturer. We provide supporting documentation and work closely with you to meet your specific compliance requirements.

Common Questions

Frequently Asked Questions

Common questions about medical-grade 3D printing services

Are your 3D printed parts safe for use in medical applications?
Our medical-grade materials are biocompatible and certified for medical use according to ISO 10993 and USP Class VI standards. However, the specific application determines suitability. We offer materials suitable for short-term skin contact, long-term skin contact, and limited direct tissue contact. Surgical guide resins can be sterilized via autoclave, EtO, or gamma radiation. For any medical application, we recommend consulting with your regulatory team to ensure the material selection meets your specific requirements and intended use.
Can you produce patient-specific anatomical models from CT or MRI scans?
Yes, we regularly work with DICOM data from CT and MRI scans to produce accurate anatomical models. We can process your medical imaging data or work with STL files you’ve already generated. Our workflow includes: receiving DICOM or STL files, 3D modeling and optimization, material selection consultation, printing and post-processing, and quality inspection. Turnaround time is typically 3-5 business days from receiving printable files. We maintain strict confidentiality for all patient data.
What sterilization methods are compatible with your materials?
Sterilization compatibility varies by material: Surgical Guide Resin supports autoclave (121°C, 20 min), ethylene oxide (EtO), and gamma radiation. High Temp Resin is autoclave compatible (134°C). Dental SG Resin supports all common dental sterilization methods. PA12 Biocompatible nylon can be chemically sterilized or use EtO. We provide specific sterilization guidelines with each order and recommend validation testing for your specific sterilization protocol before clinical use.
Do you provide documentation for regulatory submissions?
Yes, we provide comprehensive documentation packages including: material data sheets with mechanical and thermal properties, biocompatibility certificates (ISO 10993), manufacturer’s Certificate of Conformance, sterilization compatibility statements, batch/lot traceability information, and manufacturing process documentation. For FDA 510(k), EU MDR, or Health Canada submissions, we can work with your regulatory team to provide additional supporting documentation as needed.
What accuracy can you achieve for surgical guides?
For surgical guides, we typically achieve ±0.1mm accuracy using SLA printing with surgical guide resins. For dental surgical guides, we can achieve ±0.025mm (25 microns) using dental-specific resins and printers. Accuracy depends on part size, geometry, and material selection. For critical applications, we recommend discussing tolerance requirements during the quoting process. We can provide dimensional inspection reports for verification.
Can you help with design optimization for medical devices?
Yes, we offer design for additive manufacturing (DfAM) consulting specifically for medical applications. Our services include: design review for printability and biocompatibility considerations, material selection guidance based on intended use and regulatory requirements, support structure optimization for post-processing, design modifications to improve functionality and reduce cost, and recommendations for combining assemblies into single prints.
What is your typical turnaround time for medical projects?
Standard turnaround is 3-5 business days for most medical prototypes. Rush service (24-48 hours) is available for urgent surgical planning cases. More complex projects (anatomical models with multiple materials, batch production of surgical guides) may require 1-2 weeks. For ongoing medical device development projects, we can establish dedicated production schedules.
Do you work under Non-Disclosure Agreements?
Absolutely. We regularly work with medical device companies and research institutions under strict confidentiality agreements. We can execute mutual NDAs before discussing project details. All patient data is handled with complete confidentiality per healthcare privacy requirements. We maintain secure file handling processes and can discuss additional data security measures for sensitive projects.

Partner with Montreal’s Trusted Medical Device Prototyping Service

Get biocompatible prototypes with full documentation and regulatory support for your next medical device or healthcare project.