Medical Sheet Metal Fabrication

Fully Certified Medical Sheet Metal Fabrication

In medical device manufacturing, a perfect part is worthless without the paperwork to prove it. ShincoFab eliminates your regulatory risk by delivering precision sheet metal fabrication backed by 100% lot traceability, dedicated clean cells, and audit-ready documentation.

Verified Manufacturing Standards

☑️ ISO 13485:2016 Certified: Medical device quality management system (QMS) fully implemented.
☑️ ISO 9001:2015 Certified: Ensuring consistent manufacturing excellence.
☑️ FDA Registered Facility: Compliant with 21 CFR Part 820 (CGMP) and Food and Drug Administration (FDA) standards where applicable.
☑️ ITAR Registered: Secure protocols for sensitive or dual-use defense/medical technologies.

Audit-Ready Documentation & Traceability

We do not just ship physical parts. We deliver the exact documentation you need for regulatory approval.

Complete Lot Traceability: From raw material melt/heat numbers to the final shipped assembly.
Material Test Reports (MTRs): Provided with every shipment of 304, 316L stainless, and aluminum.
Advanced Inspection Protocols: First Article Inspection (AS9102 FAI reports), PPAP Level 1-3, and Certificate of Conformance (CoC) included.

Dedicated Clean Environments

Zero Cross-Contamination: Stainless steel and aluminum parts are processed in dedicated cells, strictly isolated from carbon steel fabrication to prevent sensitization or rust.
Cleanroom Packaging: Class 10,000 (ISO 7) cleanroom assembly and vacuum packaging available for mission-critical components.

Traceable Medical-Grade Materials

Medical environments are unforgiving. A wrong alloy can lead to corrosion during autoclaving or magnetic interference in an MRI suite. ShincoFab stocks the exact medical-grade materials for sheet metal fabrication your prints demand. This inventory includes biocompatible metals fully backed by complete Material Test Reports (MTRs).

316L and 304 Stainless Steel

Engineering Advantage: 316L contains Molybdenum, strictly specified to resist chloride corrosion and pitting in harsh, repetitive chemical sterilization (autoclaving) environments.
Medical Applications: Surgical instrument trays, pharmaceutical cleanroom equipment, fluid handling systems, and sterile processing components.

Titanium Grade 2 and Ti-6Al-4V

Engineering Advantage: Exceptional strength-to-weight ratio, 100% biocompatible (compliant with ISO 10993), and entirely non-magnetic (crucial for diagnostic imaging).
Medical Applications: Implantable components, MRI-safe equipment housings, and lightweight, high-strength surgical tools.

5052-H32 and 6061-T6 Aluminum

Engineering Advantage: 5052-H32 offers superior bendability for complex enclosures without cracking, while 6061-T6 provides high yield strength for rigid structural frames. Both alloys deliver excellent thermal conductivity.
Medical Applications: Diagnostic machine housings (X-Ray, CT, MRI), mobile hospital computer carts, and thermal heat sinks for medical electronics.

Copper & Brass Alloys

Engineering Advantage: Innate, continuous antimicrobial properties that naturally destroy bacteria and viruses on contact. High electrical conductivity.
Medical Applications: High-touch clinical surfaces, IV pole components, handles, and electromagnetic interference (EMI) shielding for sensitive vital-sign monitors.

Medical Fabrication Specs

Engineers shouldn’t have to play guessing games with a fabricator’s capacity. Your 3D CAD model demands strict repeatability, and our shop floor delivers it. Below are the exact machine specs we use to eliminate micro-burrs, prevent material cracking, and hold your +/- 0.005” tolerances.

Laser Cutting

Machine Specs: 4000W to 8000W automated laser cutting machines.
Capacity & Thickness: Precision cutting up to 0.500” (1/2 inch) in 316L Stainless Steel and 0.375” (3/8 inch) in Aluminum.
Medical Advantage: Dross-free, clean-edge cutting that eliminates micro-burrs—critical for surgical environments and reducing post-processing time.

CNC Press Brake Forming

Machine Specs: Multi-axis CNC press brakes ranging from 40-ton to 150-ton capacities.
Tolerances: +/- 0.005” linear and +/- 0.5 degrees angular repeatability.
Medical Advantage: Complex, multi-bend geometries executed perfectly for seamless hematology analyzer enclosures and hospital cart chassis without material cracking.

Precision Welding Solutions

Capabilities: TIG (GTAW), MIG (GMAW), Spot Welding, and advanced robotic welding cells for complete medical device metal fabrication and assembly.
Medical Advantage: Hermetic, leak-proof welding for fluid-handling devices and washdown-ready environments. Aesthetically blended clean welds for stainless steel surgical trays where bacterial harborage must be zero.

Automated Hardware Insertion

Machine Specs: CNC automated PEM® insertion presses (e.g., Haeger).
Medical Advantage: Perfectly seated flush nuts, standoffs, and studs for mounting sensitive medical PCBs, displays, and internal electronics. Zero panel warping, zero loose threads.

In-House Medical Finishing and Assembly

Routing parts between a fabricator, a plating shop, and an assembler adds weeks of delay and explodes your transit costs. Keep it under one roof. We perform medical-grade passivation, coating, and electromechanical assembly in-house. You get one purchase order, one QA audit, and zero vendor finger-pointing.

Passivation

The Process: Precise nitric and citric acid baths to chemically extract free iron and exogenous matter from 304/316L stainless steel.
The Medical Standard: Maximizes chromium oxide formation to prevent oxidation, ensuring 100% safe biological contact and compliance with FDA sterilization standards.

Medical Electropolishing

The Process: Reverse plating that actively dissolves the microscopic peaks on metal surfaces, significantly lowering the Ra (Roughness Average) value.
The Medical Standard: Creates the ultra-smooth, non-stick, and perfectly sterile finish required for surgical trays, fluid handling, and cleanroom equipment where bacterial harborage must be zero.

Medical-Grade Powder Coating & Anodizing

The Process: RoHS-compliant anodizing (Type II & III) and highly durable, chemical-resistant powder coating.
The Medical Standard: Withstands heavy hospital-grade disinfectants (bleach, IPA). Color-matched perfectly for MRI, X-Ray, and diagnostic machine housings.

Value-Added Electromechanical Assembly

The Advantage: Stop buying empty metal boxes. We deliver fully kitted assemblies.
Capabilities: We install PEM hardware, ground studs, EMI/RFI shielding gaskets, hinges, and basic electromechanical components straight to the enclosure. Ready for your production line.

Scaling Prototypes to Mass Production

The most expensive trap in medical manufacturing is using a prototype shop that cannot scale. Changing vendors after FDA clearance triggers months of costly re-auditing and design risks. We eliminate that gap. The exact ISO 13485 facility that optimizes your first prototype will seamlessly automate your million-part production run. This guarantees zero transition risk.

Phase 1: Rapid Prototyping & DFM

Fast-Turn Prototypes: Dedicated prototype cells handling rapid prototyping medical sheet metal parts, delivering First Article models in days, not weeks.
Aggressive DFM (Design for Manufacturability): We do not just build to your print blindly. Our engineers review your 3D CAD to optimize design for manufacturability, standardize hardware, and identify cost-drivers before your design is locked in.
The Result: A highly manufacturable, cost-optimized device ready for regulatory submission.

Phase 2: High-Volume Production

No Vendor Re-Qualification: Save months of auditing. The ISO 13485 quality system that built your prototype builds your production run.
Lights-Out Automation: Automated laser cells with robotic material loading… easily bridging the gap from low-volume medical device sheet metal production to massive runs of 1,000,000+ units, allowing you to seamlessly scale production volume.
Zero Tolerance Drift: Rigid statistical process control (SPC) ensures that unit #1,000,000 meets the exact microscopic +/- 0.001″ tolerances as unit #1.

Medical Device Applications

A heavy-duty MRI frame demands completely different metallurgy and tolerances than a sterile surgical tray. We do not just bend metal. We manufacture medical sheet metal parts engineered for the exact realities of your end-use environment. Whether you need complex sheet metal assemblies for medical industry imaging or custom medical enclosures sheet metal fabrication, we have proven fabrication processes to build it.

Diagnostic Imaging

Components: Heavy-duty structural frames, RF/EMI shielded enclosures, and non-magnetic patient handling panels.
Fabrication Edge: Processing large-format Aluminum and Grade 2 Titanium with multi-axis press brakes to ensure structural integrity and perfect scanner alignment.

Laboratory & Fluid Management

Components: Blood analyzer chassis, fluid pump brackets, centrifuge housings, and chromatography enclosures.
Fabrication Edge: Complex, tight-tolerance internal brackets for routing intricate tubing and mounting high-vibration motors without chassis resonance.

Surgical & Sterilization Equipment

Components: Surgical instrument trays, autoclave sterilization cases, and cleanroom workstations.
Fabrication Edge: 316L Stainless Steel processed with flush, blended welds and electropolished to a mirror-like finish (low Ra) to eliminate bacterial harborage.

Critical Care & Respiratory

Components: Ventilator external housings, internal precision brackets, and oxygen concentrator manifolds.
Fabrication Edge: High-volume progressive die stamping and automated PEM hardware insertion for rapid, scalable assembly.

Clinical Mobility & Patient Care

Components: Medical computer carts, crash carts, IV pole bases, and hospital bed frames.
Fabrication Edge: Heavy-gauge tube laser cutting and welding, finished with durable, hospital-grade, chemical-resistant powder coating.

Precision Metrology Lab

In medical manufacturing, a tolerance claim without a measurement mechanism is a liability. We do not verify microscopic +/- 0.001” tolerances with manual hand tools. We prove them with automated, programmable metrology. Our lab eliminates human error to deliver both the exact physical parts and the audit-ready dimensional reports your quality team requires.

Automated CMM Inspection

The Equipment: Multi-axis CMMs running industry-standard PC-DMIS software.
The Advantage: Fully automated, programmable 3D inspection for complex medical chassis geometries. Eliminates human operator error and generates audit-ready dimensional reports for your First Article Inspection (AS9102 FAI).

Optical Vision Systems

The Equipment: High-resolution digital optical comparators and programmable vision inspection systems.
The Advantage: Rapid, non-contact measurement of critical 2D cross-sections, micro-hole placements, and intricate radii. Crucial for verifying dross-free, zero-burr edge conditions on surgical implant components and tight-tolerance fluid management brackets.

Statistical Process Control (SPC)

The Process: Real-time data collection and capability analysis (Cp, Cpk tracking) directly from the shop floor.
The Advantage: We do not just inspect the final batch. We monitor the active process curve. SPC ensures that tooling wear or thermal expansion never causes tolerance drift during a 50,000-unit production run of ventilator enclosures.

Frequently Asked Questions

Before you upload your CAD files, you need to know how we actually do business. We do not hide our minimums (MOQs), lead times, or documentation protocols. Here are straight answers to the exact logistical questions medical engineering and procurement teams ask us every day.

What is your Minimum Order Quantity (MOQ) for medical components?

We do not enforce strict MOQs. We routinely process single-piece rapid prototypes for FDA 510(k) testing and clinical trials. Once your design is validated, we seamlessly scale to blanket orders of 10,000 to 100,000+ units using automated progressive die and laser cells.

What are your standard lead times for prototyping vs. production?

First-article prototypes typically ship in 5 to 7 business days. For high-volume production, lead times depend on material availability and finishing requirements. However, because we handle passivation, electropolishing, and assembly in-house, we consistently shave 1 to 2 weeks off traditional fragmented supply chain lead times.

My 3D CAD model isn't completely finalized. Can you still quote and review it?

Absolutely. We prefer to get involved early. Upload your current .STEP file, and our manufacturing engineers will perform a free DFM (Design for Manufacturability) review. We will flag cost-drivers, such as non-standard bend radii or difficult weld joints, before your design is locked in for regulatory approval.

What specific documentation will ship with my medical parts?

Audit-readiness is guaranteed. Depending on your PO requirements, your shipment will include full lot traceability, Material Test Reports (MTRs) from the mill, Certificates of Conformance (CoC), and finishing/plating certifications. AS9102 format First Article Inspection (FAI) reports are provided upon request.

How do you package parts to prevent contamination before cleanly assembly?

We understand that medical parts cannot arrive in a dusty cardboard box. Following passivation or ultrasonic cleaning, components can be vacuum-sealed or packed in particulate-free, anti-static bagging. This prevents cross-contamination and foreign object debris (FOD) during transit to your cleanroom facility.

Request an Online Quote for Medical Sheet Metal Fabrication

Submit your files below. Rather than handing your prints to a generic sales rep, our in-house manufacturing engineers will personally review your project and return a detailed, fully costed quote within 24 hours.