Medical

MinHon is your trusted partner for manufacturing ISO 9001 certified parts for medical devices, from diagnostic instruments to hearing aids. We apply one quality management system — aligned with medical standards — to every medical project, so you get precision parts that meet the highest standards without paying extra for cleanroom costs.

±0.0254mm Tolerance Capability | ISO 9001 & ISO 13485 Certified | NDA Available

Home
/
Medical

Precision medical components we manufacture

MinHon has delivered precision medical components since 2013 to MedTech innovators. Our cross-functional engineering team combines medical device regulatory expertise with advanced manufacturing technologies to become your extended production arm.

Diagnostic & Laboratory Instruments

Examples

Medical Imaging & Monitoring Equipment

Examples

Therapeutic & Surgical Support Devices

Examples

Wearable & Personal Medical Devices

Examples

Trusted Medical Parts Making Case Studies

Notes: Due to the NDA signed with our clients on most projects, we are only able to select and display the appearances of a few products from the medical industry after obtaining consent through communication with our clients.

Diagnostic and Monitoring Device Parts

Diagnostic Device Housing

Process:

Mold Making, Injection Molding

Materials:

ABS

Solutions:

Mass Production

Tolerance:

±0.005″

Assembly Abs Housing

Process:

Mold Making, Injection Molding

Materials:

PC+ABS

Solutions:

Mass Production

Tolerance:

±0.005″

Biomedicine and semiconductors

Biomedical chip

Process:

Machining + chemical etching

Materials:

Borosilicate Glass

Package strength:

3mpa～

Packaging process:

Polymer diffusion encapsulation

Biomedical chip

Process:

Machining + chemical etching

Materials:

Borosilicate Glass

Package strength:

3mpa～

Packaging process:

Polymer diffusion encapsulation

One-Stop Suite of Medical Precision Manufacturing Capabilities

One-Stop Solutions for Your Non-Sterile Medical Device Components

Medical Plastic Injection Molding

Ideal for high-volume production of diagnostic equipment housings, laboratory instrument panels and durable monitor bezels. Particularly suitable for customers requiring cost-effective, geometrically complex parts in medical-grade polymers.

Medical Precision CNC Machining

The optimal solution for functional prototypes, low-to-mid volume production runs and geometrically complex parts. Suitable for aluminium chassis for imaging systems, stainless steel structural brackets for medical carts and high-performance PEEK components for reusable diagnostic tools.

Medical-Grade Tooling Systems

Critical for mass production of diagnostic test cartridges, pipette trays and device enclosures. Designed for manufacturers needing high-cavitation molds with accelerated sampling cycles and validated tool lifetime.

Medical Rapid Prototyping

Accelerates development of surgical guides, diagnostic device housings and ergonomic handpiece designs. Best for R&D teams needing functional prototypes or bridge production before injection molding validation.

Surface Finishing Options

MinHon offers in-house bead blasting and screen printing for medical components alongside comprehensive outsourced surface treatments. Our vetted suppliers are certified to ISO 13485 and have partnered with us for 12+ years, helping deliver 15–22% cost savings versus market rates while ensuring full traceability and biocompatibility compliance.

For medical parts without any specific requests, we typically apply a high-gloss finish or adhere to industry standards.

Surface Treatment

Effect On Medical Components

Typical Medical Part Applications

Bead Blasting

Creates a uniform, non-glare matte texture for improved handling.

Housings for handheld diagnostic devices, equipment panels.

Pad Printing

Applies durable, wear-resistant markings, logos and instructions.

Equipment control panels, reusable instrument handles.

Electropolishing

Produces ultra-smooth surfaces reducing bacteria.

Reusable stainless steel lab trays, instrument chassis.

Passivation

Enhances the corrosion resistance of stainless steel components.

Structural brackets, fasteners, and internal support frames.

Anodizing

Forms a protective oxide layer for color coding.

Aluminium instrument panels, monitor housings, equipment frames.

PVD Coating

Creates an ultra-hard, wear-resistant surface for moving parts.

High-wear components in diagnostic machinery, robotic arms.

Silicone Spray Coating

Adds a soft-touch, non-slip finish for improved ergonomics.

Handles for portable medical devices, patient contact surfaces.

Powder Coating

Provides a durable, chip-resistant protective layer.

Medical cart frames, equipment chassis and support structures.

Medical Component Partnership Workflow

The manufacturing process of medical parts is not complicated. Throughout the entire process, all you may need to do is upload the 3D drawings and maintain communication with us.

1. Project Review & Technical Consultation

2. In-Depth Medical Parts DFM Analysis

3. Tooling Making / CNC Machining

4. Secure Packaging & Global Delivery

The Source of Your Precision

Inside Our Advanced Facility

MinHon’s dual manufacturing model offers multiple advantages. We have large-scale mass production capabilities in China and the advantage of duty-free access to the North American market in Mexico while maintaining uniform quality standards in both locations. Seeing is believing. We invite you to take a virtual tour of our clean, organized, and climate-controlled facility.

Material Option for Medical Parts Manufacturing

The medical device and healthcare industry is distinct from other sectors: many products are directly applied to the human body. We strictly adhere to industry standards in our use of materials — we consistently refuse to use recycled materials for injection molding production, and this standard is upheld in the manufacturing of parts for other industries as well.

We can provide raw material certification for all processing methods, and can also purchase from suppliers specified by clients.

Material Category

Specific Materials

Medical Certifications

Key Applications

High-Performance Polymers

PEEK, PPSU, PEI, PPS

ISO 10993, USP Class VI, FDA 21 CFR

Reusable instrument handles, structural components for diagnostic machines, manifolds.

Engineering Plastics

PC, POM, UHMWPE, COC

FDA, ROHS, REACH compliant

Diagnostic equipment housings, optical-grade covers and lenses, durable moving parts.

Medical Metals

316L Stainless Steel, Ti6Al4V (Grade 5/23), CoCrMo

ASTM F138/F139, ISO 5832-3

Structural frames for medical carts, equipment chassis, non-implant surgical tool components.

General Plastics

ABS, PP, HDPE, PVC, PS, Nylon (PA6/66)

ROHS, REACH

Enclosures for lab equipment, non-contact covers and panels, functional prototypes.

Engineering Alloys

Aluminum 6061-T6, Brass C360

ISO 9001, ASTM B221

Chassis for diagnostic equipment, heat sinks, connectors and fittings.

Medical Elastomers

Platinum LSR, TPE-S, Silicone

USP Class VI, ISO 10993-10

Seals and gaskets for diagnostic equipment, soft-touch grips for handheld devices, vibration dampeners.

High-Temp Polymers

PAI, PPS, PEEK GF30

UL94 V-0, FDA compliant

Sterilization trays, fluid handling.

Built-in Quality System

ISO 13485 & ISO 9001 Certified Medical Manufacturing

MinHon’s ISO 13485:2016 and ISO 9001:2015 certifications are engineered into our medical component production. This dual-compliance framework ensures:

Kpi

Performance

Industry Average

Material Traceability

100%

78%

Document Accuracy

99.98%

95%

CAPA Closure Time

<72 hrs

14 days

Medical Device PPM

<500

2,500

ISO 9001:2015

This certification governs our entire operation. For you, this means:

Meticulous Process Control

We utilize designated clean workstations for assembling sensitive components and maintain precise mold temperature monitoring (±1°C).

Verifiable Measurement & Monitoring

We provide 100% dimensional reports for critical components and can implement automated testing protocols, such as leak testing for sealed diagnostic cartridges.

ISO 14001:2015

We apply this medical-grade quality mindset to every project, which means:

Robust Production Controls

You receive a comprehensive First Article Inspection (FAI) report for approval before we begin full production.

Rapid & Effective Corrective Action

Our closed-loop CAPA (Corrective and Preventive Action) system ensures that any potential nonconformity is addressed and resolved in under 72 hours—a fraction of the industry average.

Trusted by Industry Leaders in Medical Technology

MinHon’s DFM review for our medical device enclosure completely transformed our project. Their team spotted 3 design issues early, cutting tooling revision cost by 22% and shortening our lead time by 3 weeks. The surface finish and dimensional stability of the molded parts exceed our strict medical requirements.

Michael Carter

Senior Product Manager

Partnering with MinHon for our precision plastic housing was a great decision. Their engineering input streamlined our part geometry, reduced material waste by 15%, and every batch maintains tight tolerance. The support is responsive throughout the whole mold development phase.

Lisa Ramirez

Mechanical Design Engineer

MinHon delivered outstanding value on our analyzer casing project. Their DFM recommendations simplified assembly structure, lowered per-unit production cost by 16%, and cosmetic quality stays consistent across mass production. We will continue to rely on them for our upcoming product launches.

David Wilson

R&D Director

Frequently Asked Questions

You mention an ISO 13485 certification. Can you clarify its scope?

Absolutely. We hold ISO 13485:2016 certification specifically for the manufacturing of components for medical hearing aids. This demonstrates our capability to operate under the rigorous quality management demands of the medical industry. We apply this same medical-grade quality mindset, including robust traceability and process controls, to every component we produce.

My application is a diagnostic instrument housing. Do I need a cleanroom?

For most diagnostic, laboratory, and external medical equipment, a certified cleanroom is not required and adds unnecessary cost and complexity to your project. Our facility is a climate-controlled, highly clean, and organized environment perfect for these applications. We focus on delivering exceptional quality and precision where it matters most for your non-sterile device.

How do you guarantee the dimensional accuracy of your components?

We guarantee accuracy through a multi-stage verification process. It begins with a detailed First Article Inspection (FAI) report, which you approve before mass production. During production, we use Statistical Process Control (SPC) and regular in-process checks. Finally, we use advanced metrology equipment, including CMMs and VMMs, for final inspection. You receive a comprehensive quality report with every shipment.

How do you ensure material traceability from Mexico production?

Our Mexico facility uses a Lot-to-Melt tracing system compliant with ISO 13485:2016 Clause 7.5.9.2. Each component batch (e.g., *VALVE-2025MX-0876*) links to:

Raw material melt certificates
Process validation records
Sterilization compatibility data

What does your Design for Manufacturability (DFM) analysis include?

Our DFM analysis is a complimentary, collaborative step to optimize your design. We analyze factors like wall thickness, draft angles, material selection, and potential for tooling simplification. The goal is to proactively identify opportunities to reduce part cost, improve molding cycle times, and enhance the long-term reliability of your component, all before any steel is cut.

What are your typical lead times for a new project?

Lead times vary by complexity, but a typical project follows this timeline: After receiving your final design, a comprehensive quote based on expert review is provided within 24-48 hours. DFM analysis takes 2-3 days. For injection molding, first shots from new tooling are typically ready in 7-15 days. For CNC machining, lead times for initial parts can be as short as 5-7 days.

What types of design files do you accept?

We accept a wide range of 3D and 2D files. For the most efficient process, we prefer 3D CAD files in STEP (.stp), IGES (.igs), or Parasolid (.x_t) formats. We can also work with native files from SolidWorks, and we require 2D drawings (in PDF or DWG) to specify critical tolerances, threads, and surface finishes.

Can your inspection detect particulate contamination in clear components?

Yes. Our System detects ≥5μm particulates in transparent parts (e.g., IV connectors) with:

Accuracy: 99.97% (vs. 92% manual inspection)
Speed: 500 parts/minute
Compliance: FDA 21 CFR Part 11 audit trail

How quickly can China/Mexico production shift for Class III device emergencies?

72-hour activation protocol:

Hour 0-24: Process validation at MX facility (using China-qualified tools)
Hour 24-48: First-article inspection (FAI per AS9102)
Hour 48-72: Volume ramp-up (max. 200k parts/week)

What real-time monitoring is available for overseas implant production?

Clients access:

Live Process Feeds: Machine sensors (e.g., temperature, pressure)
Quality Gates: Dimensional checks via in-line CMMs
Alerts: SMS/email for deviations (e.g., ±0.01mm tolerance breach)