Medical Device Plastic Housings | Custom OEM Enclosures

OEM custom plastic housings engineered for medical electronics, diagnostic hardware, and clinical devices. Built to exact CAD specifications, our enclosures balance structural rigidity, aesthetic ergonomics, and stringent regulatory compliance within an ISO 13485 certified manufacturing environment. We manage the full lifecycle from DFM (Design for Manufacturability) and rapid tooling to in-house cleanroom injection molding and secondary assembly.

Specifications

Parameter	Standard Capability / Specification Options
Manufacturing Process	Precision Plastic Injection Molding, Insert Molding, Overmolding
Supported Resins	PC, ABS, PC/ABS, PMMA, TPU, PEEK, PSU (Medical-grade & biocompatible available)
Flammability Rating	UL94 V-0 / V-1 / HB
Dimensional Tolerance	Up to +/-0.02 mm (High-precision tooling)
Surface Finish	VDI 3400 / SPI texturing, high-gloss polish, chemical-resistant matte texture
Ingress Protection	Integrated gasket sealing up to IP65 / IP67
Regulatory Compliance	ISO 13485 certified manufacturing, FDA-registered facility standards

Features

Biocompatible Material Selection: Utilization of verified medical-grade resins compliant with ISO 10993 and USP Class VI requirements for patient-contact applications, backed by full regional compliance alignment (FDA-registered facility standards and EU MDR material compatibility).

Ergonomic & Cleanable Geometry: Smooth radii, seamless exterior transitions, and chemical-resistance designed to withstand frequent hospital-grade sanitization agents (e.g., isopropyl alcohol, hydrogen peroxide, bleach solutions).

EMC / RFI Shielding Options: Optional internal conductive coating (nickel-copper spray or vacuum metallization) to prevent electromagnetic interference in sensitive diagnostic equipment.

Tight Tolerance Assembly Integration: Built-in threaded brass inserts, snap-fit joints, and alignment ribs designed for secure PCB mounting and repetitive enclosure servicing.

Materials & Manufacturing

Material Options
PC/ABS Blends: High impact resistance and dimensional stability; ideal for handheld monitors and diagnostic devices.

Polycarbonate (PC): High optical clarity and impact strength; used for light pipes, display windows, and transparent covers.

Medical-Grade ABS: Cost-effective, rigid housing for stationary lab equipment and desktop housings.

Manufacturing Process & Facility
Molding Equipment: Electric and hybrid injection molding machines ranging from 80T to 550T, equipped with closed-loop process monitoring.

Cleanroom Production: ISO Class 7/8 cleanroom environments available for molding and secondary assembly of sensitive patient-facing components.

Tooling Capabilities: In-house tool room utilizing high-speed CNC machining and EDM for rapid mold iteration and tool life guarantee up to 500,000+ shots.

In-House Secondary Operations: Complete vertical integration covering ultrasonic welding, pad printing, laser etching, and in-house insert placement to eliminate supply chain bottlenecks and safeguard quality.

Applications

Diagnostic & IVD Equipment: Point-of-care testing units, blood analyzer exteriors, and nucleic acid testing device chassis.

Patient Monitoring Systems: Bedside monitor bezels, telemetry transmitter cases, and portable vital signs units.

Surgical & Therapeutic Devices: Handheld surgical tool handles, infusion pump housings, and laser therapy controller consoles.

Customization

We support full-custom OEM/ODM manufacturing based on 3D/2D engineering drawings (STEP, IGES, SolidWorks, PDF):

DFM & Mold Flow Analysis: Provided prior to tooling fabrication to eliminate sink marks, weld lines, and warping.

Secondary Operations: In-house ultrasonic welding, pad printing, laser etching for serial numbers/logos, and EMI shielding application.

Prototyping Phase: CNC machining and SLA/SLS rapid prototypes delivered for mechanical fit and functional testing before production tooling investment.

QC

Quality assurance aligns with ISO 13485 medical standards across all production stages:

Incoming Raw Material: Resin lot verification, melt flow index testing, and moisture content analysis.

In-Process Inspection: Automated optical inspection (AOI) and first-article inspection (FAI) utilizing CMM (Coordinate Measuring Machines) for critical dimensions.

Functional & Cosmetic Testing: Drop impact testing, peel tests for painted/printed surfaces, and IP seal leak testing.

Traceability: Full material lot traceability documentation provided with each shipment.

FAQ

Q: Can you provide raw material compliance documentation?

A: Yes. All resins are supplied with manufacturer-certified Certificate of Analysis (CoA), RoHS, REACH, and biocompatibility declarations (ISO 10993 / USP Class VI) upon request.

Q: What is your standard lead time for injection mold tooling?

A: Tooling fabrication typically ranges from 3 to 6 weeks depending on part complexity and cavity count. T1 samples are delivered alongside full measurement reports.

Q: Do you sign NDAs before reviewing project drawings?

A: Yes. We routinely execute Mutual Non-Disclosure Agreements (NDAs) to protect your intellectual property and proprietary device designs prior to technical review.

RFQ

To receive a formal quotation within 24 hours, please provide the following technical details via email or our inquiry form:

3D CAD files (STEP / IGES format) and 2D drawings with tolerance requirements.

Estimated annual volume / batch size.

Specified resin grade or performance requirements (e.g., UL94 V-0, sterilization method).

Surface finish, color requirements (Pantone code), and secondary processes (printing, shielding, inserts).

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