Medical Equipment Manufacturing
A medical device contract manufacturer for precision components and full assemblies used in diagnostic, surgical, laboratory, and patient care equipment, from prototype to validated production under one IATF 16949:2016 certified partner.
Why Medical Device OEMs Choose Meco
Meco manufactures Class I and Class II medical components and non-sterile assemblies under one NDA-protected, IATF 16949:2016 certified supply chain.
Custom Medical Manufacturing Processes
Eight in-house metalworking, polymer molding and assembly capabilities for prototype and production medical hardware.
5-Axis CNC Machining
Surgical instrument bodies, manifolds and PEEK/titanium parts milled to ±0.01 mm (Ra 0.4 μm).
5-Axis CNC Machining →
Swiss & CNC Turning
Trocar housings, guide pins, endoscopic shafts, fluid fittings and miniature medical fasteners.
CNC Turning →
Die Casting
Thin-wall aluminum and zinc enclosures, EMI-shielded monitor chassis and imaging frames.
Die Casting →
Investment Casting
Near-net-shape 316L and 17-4 PH stainless instrument jaws, hinges, valve bodies and bed joints.
Investment Casting →
Plastic Injection Molding
Molded PC, ABS, PPSU, PEEK and overmolded handheld diagnostic enclosures and trays.
Injection Molding →
Sheet Metal & Stamping
Laser-cut and progressive-die stamped stainless trays, analyzer chassis, carts and spring clips.
Sheet Metal Stamping →
Passivation & Finishing
Citric/nitric passivation (ASTM A967), electropolishing, hardcoat anodizing and medical powder coat.
Surface Finishing →
Electromechanical Assembly
Turnkey sub-assembly, PCBA integration, permanent UDI laser marking and functional testing.
Mechanical Assembly →Custom Medical Parts by Equipment System
Precision metal and polymer components engineered for hygiene, sterilization durability and repeatable accuracy across Class I and Class II healthcare equipment.
Diagnostic Imaging & Radiology
Gantry housings, detector frames, collimator brackets and EMI-shielded enclosures die cast and CNC milled for MRI, CT, X-ray and ultrasound systems.
Surgical & Reusable Instruments
Handles, forceps jaws, retractors, guide pins and trocar housings 5-axis machined and passivated in 316L, 17-4 PH, 420 stainless and Ti-6Al-4V.
Patient Monitoring & Diagnostic Carts
Injection-molded and die-cast bedside monitor housings, sensor mounts, battery bays and extruded aluminum medical cart arms.
Laboratory & Analytical Equipment
Centrifuge rotors, sample trays, optical housings and fluidic valve bodies CNC machined from chemically resistant 316L, PEEK and PTFE.
Dental Chairs, Handpieces & Sterilizers
Cast chair frames, Swiss-turned handpiece bodies, tray brackets, headrest mechanisms and passivated stainless sterilizer components.
Medical Materials & Sterilization Compatibility
Compare how the metals and medical polymers Meco machines, casts and molds respond to repeated reprocessing across common sterilization routes.
| Material & Grades | Typical Medical Application | Steam Autoclave | Gamma | EtO |
|---|---|---|---|---|
| 316 / 316L Stainless | Instrument bodies, fluid-path fittings, trays, frames | Suitable | Suitable | Suitable |
| 17-4 PH / 15-5 PH Stainless | High-strength surgical shafts, forceps jaws, pivots | Suitable | Suitable | Suitable |
| 420 / 440C Stainless | Hardened cutting, clamping & gripping features | Passivate first | Suitable | Suitable |
| Titanium Grade 2 & Grade 5 | Lightweight surgical instruments & ultrasonic horns | Suitable | Suitable | Suitable |
| Aluminum 6061 / 6082 / ADC12 | Imaging gantry frames, monitor housings, carts | Coating wears | Suitable | Suitable |
| PEEK | Reusable high-heat insulators, handles, manifolds | Suitable | Suitable | Suitable |
| PPSU (Radel) & PEI (Ultem) | Sterilization trays, reusable connectors & housings | Suitable | Suitable | Suitable |
| PTFE (Teflon) | Chemically inert seals, bearings & fluid valves | Suitable | Not suitable | Suitable |
| Polycarbonate (PC) | Transparent guards, bezels & single-use housings | Not suitable | Yellowing risk | Suitable |
| Nylon (PA6, PA66) & POM | Structural clips, gears & non-critical mechanisms | Moisture shift | Embrittlement | Suitable |
Meco supplies EN 10204 3.1 mill certs and resin CoAs to support your ISO 10993 biological evaluation. See our medical plastics guide and medical CNC guide.
Ready to Start Your Medical Project?
Send us your CAD files and drawings under NDA for a quote and DFM review within 24 hours.
Medical Surface Finishes & Passivation
Citric/nitric passivation, low-bioburden electropolishing, anti-glare blasting and hospital-grade coatings finished to your drawing specification.
| Finish | Compatible Materials | Standard & Medical Use |
|---|---|---|
| Citric & Nitric Passivation | Stainless steel (304, 316L, 17-4 PH, 420) | ASTM A967 / AMS 2700; removes free iron for autoclave corrosion resistance |
| Electropolishing | Stainless steel, titanium | ISO 15730; ultra-smooth Ra ≤ 0.2 μm micro-finish prevents bacterial adhesion |
| Anodizing (Type II & III Hardcoat) | Aluminum, titanium | MIL-A-8625 (Al); AMS 2488 (color-coded Ti surgical handles & housings) |
| Micro-Bead Blasting & Tumbling | Stainless steel, titanium, aluminum | Matte satin anti-glare finish for surgical instruments under OR lighting |
| Electroless Nickel & Chrome | Steel, aluminum, brass, copper | ASTM B733 / AMS 2406; wear-resistant fluid manifolds & dental mechanisms |
| Antimicrobial Powder & Liquid Coat | Aluminum, steel, cast enclosures | ISO 2409; chemical-resistant coatings for hospital carts, beds & monitors |
Every lot can be laser-marked with permanent UDI bar codes, serial numbers or lot codes before shipping.
Medical Quality Assurance & ISO 13485 Mapping
Meco's IATF 16949:2016 quality system produces the objective component evidence required by your ISO 13485 supplier file, Device History Record (DHR) and ISO 14971 risk file.
FAI & APQP Design Transfer
Ballooned FAI reports and phase-gated APQP launch controls for structured design transfer.
PPAP & Frozen Process Control
Control plans, process flow, MSA and written change-control notification before any process shift.
CMM & CTQ SPC Tracking
CMM probing to ±0.002 mm with GD&T layout reports and ongoing Cpk capability data.
PFMEA Risk & NDT Inspection
Documented PFMEA feeding your ISO 14971 risk file, plus ultrasonic, FPI and X-ray NDT.
DHR Lot & Serial Traceability
Heat-lot and resin-batch tracking feeding directly into your Device History Record (DHR).
EN 10204 3.1 Certs & Resin CoA
Mill test reports, polymer Certificates of Analysis and passivation certs with every shipment.
REACH & RoHS Compliance
Full EU REACH and RoHS substance declarations for raw alloys, polymers and coatings.
Conflict Minerals (CMRT)
CMRT declarations verifying conflict-free 3TG smelter sourcing under SEC rules.
What Meco Supplies (Class I & II Non-Sterile)
- Machined, cast, molded, stamped & forged parts to your print
- Electromechanical & box-build assemblies with PCBA integration
- PPAP, FAI, CMM, EN 10204 3.1 & DHR lot traceability records
- Supply chain management & customer-owned production tooling
Retained by the Legal Device Manufacturer
- Finished-device ISO 13485 QMS & regulatory submissions (FDA / MDR)
- ISO 10993 biological evaluation & biocompatibility testing
- Terminal sterilization & sterile-barrier packaging validation
- Implantable (Class III) or sterile-packaged finished devices
Medical Equipment Manufacturing FAQ
Is Meco a qualified supplier for ISO 13485 medical device OEMs?
Yes. While Meco does not hold standalone ISO 13485 registration, our IATF 16949:2016 quality system enforces APQP, PPAP, PFMEA, SPC and frozen process change control. As an upstream component and sub-assembly partner, we provide full FAI reports, CMM data, EN 10204 3.1 mill certificates and lot traceability for your ISO 13485 Device History Record (DHR).
What types of medical parts do you make, and do you supply sterile implants?
We manufacture non-sterile Class I and Class II medical components and assemblies—including diagnostic imaging housings, reusable surgical instruments, IVD lab hardware, patient monitors and hospital bed mechanisms. We do not manufacture implantable devices or sterile-barrier packaged products.
What tolerances and surface finishes can you hold on medical parts?
We hold ±0.01 mm CNC machining tolerances and surface roughness down to Ra 0.4 μm (Ra ≤ 0.2 μm with electropolishing), verified on CMMs to ±0.002 mm accuracy per ISO 2768 and ISO 286.
Which materials do you recommend for steam autoclave sterilization?
For repeated steam autoclaving, 316L and 17-4 PH stainless steel (passivated per ASTM A967), Titanium Grade 2 and Grade 5, PEEK and PPSU retain dimensional stability and surface finish. We supply full mill and resin certificates to support your ISO 10993 biological evaluation.
Can you support low-volume prototypes and scale to production tooling?
Yes. There is no minimum order quantity for CNC-machined or 3D-printed prototypes (shipping in 1–2 weeks). When your program scales to die casting, injection molding or stamping, we build the tooling and you retain 100% ownership of all molds and dies.
Where are your factories and how do you protect our IP?
We sign mutual NDAs before reviewing files and manufacture in our own IATF 16949-certified facilities in Thailand (20,000 m²) and China (16,000 m²), backed by U.S. engineering teams and corporate headquarters in Richmond Hill, Ontario, Canada—never brokering your CAD files to outside bidding networks.
From Medical Prototype & FAI to Validated Production
We sign an NDA first. Send 3D CAD models, 2D drawings with GD&T, alloy/resin callouts, sterilization route and target volume.
Our engineers reply within 24 hours with itemized pricing and DFM feedback that typically cuts part or tooling cost by 15–30%.
Machined parts go straight to first articles; for cast, molded or stamped parts, we build dedicated tooling that you own 100%.
Before serial production, we deliver T1 samples with your First Article Inspection report, CMM data, passivation certs and mill/resin CoAs.
Meco runs SPC-monitored production under strict change control, handling UDI laser marking, sub-assembly and worldwide delivery.
Medical Manufacturing Guides
Medical CNC Machining
Alloys, tolerances, surface finishes and inspection for healthcare hardware.
Read the guide ›
Medical Plastics & Sterilization
How to select and machine PEEK, PPSU, PTFE and PC for medical devices.
Explore materials ›
Medical Device Assembly
How machined, cast and molded parts become validated device assemblies.
Learn more ›
Prototyping to Production
Scaling from first-article prototypes to validated volume runs for medical OEMs.
Read the guide ›Send Your Files, Get a Reply in 24 Hours
Prototype or production, we review every request and reply with clear next steps.
- Engineering feedback with every quoteWe review your files and reply with manufacturing feedback that can reduce cost.
- Send what you haveUpload drawings or 3D models, or describe the part and we'll help define the rest.
- Prototype to production, no minimum orderStart with one sample and scale to repeat production runs.
- One partner, 40+ processesMachining, casting, forging, stamping, finishing and assembly, under an IATF 16949:2016 quality system.
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