Medical Equipment Frames & Device Support Structures for Medical Devices

We fabricate custom support frames and structural assemblies for diagnostic and therapeutic medical equipment from biocompatible stainless steel and medical-grade aluminum with ±0.5–1.0 mm assembly tolerances. Cleanroom-compatible materials and sterilization-friendly finishes. FDA compliance support. Lead times from 7–14 business days. Upload STEP/IGES/DWG — 48h DFM & quote.

Upload Drawings Why Choose Us

Accepted Formats: STEP · IGES · DWG · SLDPRT · PDF

Custom Design & Medical Compliance

Working from concepts, sketches, or existing designs, our engineering team evaluates CAD drawings for load-bearing requirements, sterilization compatibility, and cleanroom integration feasibility.

Through Design-for-Manufacturing reviews and biocompatible material selection guidance, we transform medical device concepts into manufacturable, compliant structures that balance performance, durability, and regulatory requirements.

Biocompatibility material selection and sterilization compatibility
Cleanroom-compatible surface finishing and documentation
Patient safety load analysis and structural validation
FDA traceability documentation planning

Engineering Review Process

Our technical team collaborates directly with your designers to identify optimization opportunities and ensure FDA compliance readiness before fabrication begins.

Timeline: Upload design → 48h DFM feedback → Quote with regulatory notes → Prototype or production run with full documentation

Precision Tube Fabrication & Medical-Grade Welding

Behind every smooth curve and clean weld is a quality-controlled process designed for biocompatible medical applications. We integrate CNC mandrel bending, laser cutting, and certified TIG welding into seamless production workflows.

CNC Tube Bending

Mandrel bending for non-stress-cracking curves with material consistency. Typical tolerances ±0.3–0.8 mm for sterile device applications.

Laser Tube Cutting

Precision cutting with burr-free edges and smooth internal surfaces to meet cleanroom standards. Tolerances ±0.05–0.1 mm for mounting interfaces.

TIG/MIG Welding

Certified welding with minimal porosity and smooth seams for biocompatible applications. 100% visual inspection with surface finish validation.

Biocompatible Materials & Surface Finishing

Material Options

Medical applications demand biocompatible, sterilization-compatible materials. We specialize in stainless steel and medical-grade aluminum with proven performance in diagnostic and therapeutic devices.

316L Stainless Steel — Superior biocompatibility for patient-contact applications
304 Stainless Steel — Cost-effective for non-patient-contact structures
6061-T6 Aluminum — Lightweight for mobile diagnostic equipment
Titanium Alloys — When extreme biocompatibility and strength are required

Material selection guidance provided during DFM review based on patient contact, environmental exposure, and sterilization requirements.

Medical-Grade Finishing

Electropolishing — Enhanced corrosion resistance and cleanroom compatibility
Passivation — ASTM A967 passive layer for sterilization durability
Mirror Polishing — High-gloss finish with minimal particle shedding
Anodizing (Type II/III) — Hard-coat protection for aluminum with biocompatible seals

Every surface treatment is selected for biocompatibility, sterilization durability, and compliance with medical device standards (ISO 13485, FDA CFR Part 11).

Medical Device Integration Features

Beyond basic frame structures, we design equipment support systems with integrated features for diagnostic imaging, therapeutic delivery, and patient safety.

Diagnostic Device Mounting

Precision frames for imaging equipment, ultrasound systems, and diagnostic instrumentation with vibration-damping provisions.

Therapeutic Equipment Support

Robust support structures for rehabilitation equipment, surgical systems, and patient-contact device frames.

Cleanroom-Compatible Design

Materials and finishes optimized for cleanroom environments with minimal particle shedding and compatibility with sterilization protocols.

Quality Assurance & FDA Compliance Readiness

Precision and compliance are not claims — they're measured and documented at every stage of production under our ISO 9001 certified quality management system.

Measured Tolerances

Precision Standards

Laser cutting:±0.05–0.1 mm
Tube bending:±0.3–0.8 mm
Welding assembly:±0.5–1.0 mm (fixture-controlled)
Total frame:±1.0–1.5 mm (final assembly)

All tolerances confirmed at quote based on specific geometry and regulatory requirements.

Regulatory Documentation & Traceability

Full process traceability with documented inspection at each stage ensures FDA compliance readiness and comprehensive device history records.

First Article Inspection (FAI) reports
In-process inspection logs with measurements
Final dimensional verification and surface inspection
Certificate of Conformance (CoC) with material certifications
Certificate of Analysis (CoA) for biocompatible material batches

ISO 13485 Pathway

Our ISO 9001 quality system and documented processes provide foundation for ISO 13485 medical device manufacturing qualification.

Application Examples

Custom fabrication for diverse medical equipment ranging from diagnostic imaging to surgical support systems.

Ultrasound System Frame

Modular support structure for portable ultrasound equipment. Stainless steel with polished surfaces for easy cleaning and sterilization.

Surgical Robot Mount

Precision-mounted framework for collaborative surgical robotics with integrated cable management and tool attachment interfaces.

Patient Transport Equipment

Heavy-duty aluminum frame with integrated handles and locking mechanisms for safe, repeatable patient positioning.

Why Partner with X-KPR for Medical Device Fabrication

When medical equipment frames need to move from design to FDA-compliant production assemblies, X-KPR brings engineering rigor, biocompatible expertise, and proven quality systems.

Medical Device Expertise

Proven experience with medical OEMs and device manufacturers. We understand regulatory requirements, biocompatibility standards, and traceability documentation.

End-to-End Integration

Tube bending, laser cutting, welding, passivation, and quality inspection under one roof. Full process traceability for FDA and regulatory compliance.

ISO 13485 Roadmap

Currently ISO 9001 certified with documented processes and quality systems supporting pathway to ISO 13485 medical device manufacturing qualification.

Frequently Asked Questions

What materials are recommended for medical device frames?

316 stainless steel is the preferred choice for biocompatible, corrosion-resistant applications. 304 stainless steel is suitable for non-patient-contact structures. We also work with medical-grade aluminum (6061-T6) for lightweight applications. All materials are selected for compatibility with sterilization methods (autoclaving, ethylene oxide, gamma radiation).

Are your processes compatible with sterilization requirements?

Yes. Our tube finishing (polishing, passivation) and surface treatments are optimized for steam sterilization (121°C autoclaving) and chemical sterilization. We avoid materials and finishes that degrade under repeated sterilization cycles.

Can you support FDA compliance documentation?

Yes. We provide comprehensive traceability records, material certifications (Mill Certificates of Conformance), process documentation, and Certificates of Analysis. Our ISO 9001 quality system creates the foundation for FDA compliance. Specific regulatory support is discussed during the quote phase.

Do you fabricate complete assemblies or frame structures only?

Both. We can deliver bare frame structures or fully assembled equipment with integrated cable routing, mounting points, and sensor/component integration. Assembly scope is customized based on your device requirements.

What lead times can you offer for medical devices?

From 7–14 business days after design approval, depending on complexity, material availability, and surface finishing requirements. This includes fabrication, welding, passivation (if required), and final inspection with full documentation.

How do you handle cleanroom-compatible manufacturing?

We follow cleanroom protocols during finishing and assembly stages: controlled handling, minimal particle generation, documented cleanliness verification, and packaging suitable for controlled environments. Specific cleanroom class requirements are addressed in DFM review.

Request a Quote — Upload Your Drawings

Send us your CAD files, material preferences, sterilization requirements, and regulatory considerations. We'll return DFM feedback and a detailed quote within 48 hours.

Upload Drawings & Get a Quote Contact Engineering Team