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Custom Medical Device Housings Manufacturer

DEK has extensive experience in manufacturing medical device housings, offering on-demand production of biocompatible medical prototypes with high surface finish at highly competitive prices. From early prototypes to final products, we have comprehensive facilities and expertise to realize the most complex designs, with in-house quality control compliant with ISO 13485 standards.
Contatto
Medical Device Housings
Introduction

Precision Manufacturing for Medical Device Enclosures

Precision  Manufacturing for Medical Device Enclosures

Medical device housings require high dimensional accuracy, tight assembly tolerances, and flawless surface finishes to meet hygiene and functional demands. Material selection and sharp edge control further add to the machining complexity.

DEK employs multi-axis CNC milling with edge-breaking and fine deburring processes to achieve sharp geometry without burrs. We use validated process flows with traceable material lots to maintain dimensional stability and surface integrity.

Each housing is inspected for tight fits, surface quality, and material compliance using optical CMM, surface profilometers, and visual standards under ISO 13485 protocols.

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±0.01mm Tolerance

Maintained across critical mounting and sealing interfaces.

Ra 0.4μm Finish

Mirror-finished or brushed surfaces available per requirement.

ISO 13485 Certified

All production meets medical device compliance needs.

Biocompatible Coatings

Anodizing and passivation per ASTM and ISO standards.
capabilities

Capacità di lavorazione

5-Axis Milling for Complex Geometry

5-axis CNC milling ensures precise cutting of undercuts, internal ribs, and contoured shapes critical for ergonomic and functional housing design. This reduces setups and improves repeatability.

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Anodizing for Biocompatibility

We apply Type II and Type III anodizing with RoHS and ISO 10993 compliance. Thickness is tightly controlled (±2μm) and traceable per part number and batch.

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Deburring and Edge Management

Edges are hand-finished with medical-grade tools. Controlled edge breaks (R0.2–R0.5mm) ensure safety in handling and reliable sealing in assembled products.

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Material Traceability and Lot Control

All aluminum, stainless steel, and titanium grades are sourced with full mill certs. Each housing is marked with batch info for traceability.

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Optical & CMM-Based Inspection

Hole alignment, flatness, and surface quality are verified with CMM, height gauges, and optical scopes.

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Certified Material Compliance

We source 6061-T6, 316L, and Ti-6Al-4V with full RoHS and REACH documentation. Spectrometer verification is conducted in-house before machining.
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Medical-Grade Clean Handling

Post-processing and inspection follow ISO 13485 cleanliness protocols. Gloves, sealed pouches, and anti-static bags are used where required.
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In-Process SPC and Lot Control

Statistical Process Control is applied at critical dimensions. Each batch includes in-process logs and final inspection data.
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Packaging with Protective Sealing

We apply foam inserts, anti-scratch layers, and individual bagging. Export-grade cartons or wood crates are used based on weight and volume.
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Cross-Team Engineering Support

Our team includes DFM engineers, materials experts, and ISO auditors to ensure compliance from prototype to volume delivery.
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TESTIMONIALS

Testimonianze

Cosa ci rende diversi

DEK provides the precision, speed, and zero-defect manufacturing that mechanical engineers trust for their most critical applications.

Contatto
6–12

6–12 Hour Quotes

You’ll receive your quote in under 12 hours—no auto-pricing, real engineering review.
1 Piece

1 Piece MOQ

We support pilot builds from one unit, with the same process flow as mass production.
20%

20% Cost Efficiency

Our optimized toolpaths and process design lower costs without compromising quality.
FAQ

Alloggiamento per dispositivi medici Domande frequenti sull'acquisto

Quotes are ready in 6–12 hours. Send your drawing via our citazione page.
We hold ±0.01mm on critical areas, verified via CMM and SPC reports.
6061-T6, 7075, 316L, and Ti-6Al-4V—all with certs and RoHS compliance.
Yes, starting from 1 unit. Full inspection and process control included.
Anodizing, electropolishing, passivation. Ra 0.4μm achievable on request.
Typical 7–10 working days for prototypes; 2–4 weeks for batches.
Yes, including CMM, material certs, FAI, and visual inspection per ISO.
Absolutely. Email us at quote@dekmake.com and we’ll send one right away.
Yes, we offer DFM feedback to ensure machinability and reduce cost.

Put Your Medical Device Housing into Production Today

Send us your drawing—we’ll provide fast DFM feedback and a precise quote, no minimum order.

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DEK
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