Medical Device
Manufacturing
Empowering life-saving ideas through diligence and transparency. 3DPX Medical is an FDA registered medical device manufacturer with ISO 13485 certification.
Medical Manufacturing Services
From prototyping through production, we provide comprehensive medical device manufacturing with full quality traceability and regulatory compliance.
Biocompatible Materials
Medical-grade nylon and biocompatible materials suitable for patient-contact applications and implantable device components.
Prototyping & Development
Rapid prototyping services to accelerate your medical device development cycle. Iterate quickly with production-grade materials.
Engineering & Testing
Design-for-manufacturing optimization, FEA analysis, and testing services to ensure your device meets all performance requirements.
Regulatory Guidance
Navigate FDA requirements with confidence. Our quality team provides guidance on regulatory pathways and documentation.
Supplier Agreements
Formal quality agreements, supply chain documentation, and traceability protocols for medical device manufacturers.
Production Manufacturing
Scale from prototype to full production with consistent quality. Batch traceability and inspection reports for every order.
From Concept to Production
Concept to completion, we work with you to leverage your specific expertise and innovative spirit. Our quality control and compliance team verify regulatory requirements and quality tolerances to ensure you meet FDA guidelines.
Concept
Share your ideas, sketches, or existing designs with our engineering team.
Design
Our engineers create production-ready CAD files optimized for manufacturing.
Prototyping
Rapid prototypes in production materials for form, fit, and function testing.
Iteration
Refine designs based on testing feedback and specifications.
Compliance
Quality verification, documentation, and regulatory review.
Production
Full-scale manufacturing with batch traceability and inspection.
Our Promise
We will always keep our mission in mind to empower life-changing ideas through diligence and transparency. We put checks and balances in place to ensure we produce what you expect. We do not make this promise lightly and take the utmost pride in our work.
Have a Medical Device Project?
Contact our team to discuss your medical device manufacturing needs. FDA registered facility with ISO 13485 certification.