From DFM to production, ISO 13485-controlled manufacturing ensures traceability, compliance, and consistent quality.
Delivery in 3 days Accuracy ±0.01mm Materials traceability 100%
We combine key manufacturing processes to support medical device development at every stage—from prototyping and validation to low- and mid-volume production.
With CNC Machining, Injection Molding, Urethane Casting, Sheet Metal Fabrication, and secondary operations under one roof, we help teams reduce supplier handoffs, shorten lead times, and maintain greater consistency throughout development.
Turning part design into high-precision components for engineering validation and assembly trials. With 3-, 4- and 5-axis CNC machines running 24/7, we help teams iterate faster while delivering consistent quality.
Ideal for bridge production and volume manufacturing, with options for overmolding, insert molding and family molds to optimize cost and throughput.
Fast, cost-effective way to produce small-batch medical plastic parts for design validation, functional testing, and pilot builds—without committing to expensive tooling. Ideal for complex housings and functional structures.
Including laser cutting, bending, welding, finishing, and assembly—for medical device enclosures, structural components, mounting brackets, and instrument housings.
From early development to production, our manufacturing services
support a variety of medical device applications. Here are some examples we frequently help bring to life.
Click below to filter by material attribute and browse suitable options for regulated medical applications.
PEEK
Polyether Ether Ketone
High-performance plastic with excellent strength, stability, and sterilization compatibility.
Typical Applications
PEI
Polyetherimide
Rigid engineering plastic with high heat resistance and excellent dimensional stability.
Typical Applications
PC
Polycarbonate
Transparent plastic with high impact resistance and a clean cosmetic finish.
Typical Applications
PP
Polypropylene
Lightweight plastic with good chemical resistance and cost efficiency.
Typical Applications
Aluminum
Aluminum Alloy
Lightweight metal with good machinability, corrosion resistance, and strength-to-weight performance.
Typical Applications
316L SS
316L Stainless Steel
Medical-grade metal with excellent corrosion resistance, strength, and machining performance.
Typical Applications
PA
Nylon
Durable engineering plastic with excellent mechanical strength and self-lubrication.
Typical Applications
POM
Acetal
Rigid, low-friction polymer often used for precise moving parts.
Typical Applications
PA6+GF30
Glass Fiber Reinforced Nylon
Glass fiber reinforced nylon with enhanced stiffness, strength, and thermal stability.
Typical Applications
PTFE
Teflon
Self-lubricating and chemically inert polymer with exceptional wear resistance.
Typical Applications
PEEK
Polyether Ether Ketone
High-performance polymer retaining strength and stability above 250 °C.
Typical Applications
PPS
Polyphenylene Sulfide
Engineering plastic with continuous use above 200 °C and inherent flame retardancy.
Typical Applications
PC/ABS
Blend
Blend material combining PC toughness with ABS processability.
Typical Applications
ABS
Acrylonitrile Butadiene Styrene
Tough plastic with dimensional stability and versatile finishing options.
Typical Applications
PP
Polypropylene
Versatile polymer with toughness, fatigue resistance, and chemical stability.
Typical Applications
TPE/TPU
Thermoplastic Elastomer / Polyurethane
Flexible, rubber-like plastics with excellent elasticity and abrasion resistance.
Typical Applications
LDPE/HDPE
Polyethylene
Durable, versatile plastics widely used in storage and structural parts.
Typical Applications
PS
Polystyrene
Clear plastic with good dimensional stability but low impact resistance.
Typical Applications
PC
Polycarbonate
Extremely tough and transparent polymer for demanding visual and functional uses.
Typical Applications
PP
Polypropylene
Versatile polymer with toughness, fatigue resistance, and chemical stability. Food-grade options available.
Typical Applications
LDPE/HDPE
Polyethylene
Durable, versatile plastics widely used in storage and structural parts. Excellent for food contact applications.
Typical Applications
PTFE
Teflon
Self-lubricating and chemically inert polymer with exceptional wear resistance. Food-grade options available.
Typical Applications
* For more material requirements, please contact our experienced engineering team here.
ISO 13485–based quality system combining expert teams, advanced inspection equipment, and structured quality processes.
Professional QC specialists with strict quality management practices
Quality control planning at the project review stage (DFM & risk review)
Full quality traceability from raw materials to delivery
Incoming materials inspection: XRF analyzer, Infrared C & S Analyzer
Dimensional and geometry inspection: • CMM • 2D Image Measuring Machine • Flash Measuring Machine • 3D Scanning System
IQC: Incoming Material Inspection for compliance verification
FAI: First Article Inspection with full dimensional reports
IPQC: In-process inspection and critical dimension monitoring
OQC: Final inspection with CoA / CoC documentation
FDA Class I & II / EU MDR Support
ISO 13485 / ISO 9001 / ISO 14001 Certified
Traceability & Documentation Control
Challenge: Complex geometry, tight tolerances, and EMC needs
Solutions: CNC + Injection molding + EMC coating
Result: Lead time reduced by 50% and cost reduced by 30%
Challenge: 400 units/year with flexible batch and consistent quality
Solutions: CNC + Injection Molding + Urethane Casting
Result: Lead time reduced by 50% and cost reduced by 70%
Challenge: Low annual demand of 500 units with complex geometry
Solutions: Urethane Casting for flexible low-volume production
Result: Cost reduced by 80% and development cycle cut by 50%
Challenge: Complex and precision structure for small-batch medical parts
Solutions: CNC + Urethane Casting for prototyping and low-volume production
Result: Enabled stable, cost-effective small-batch manufacturing
From file review to delivered parts, our workflow helps medical teams improve visibility, traceability, and execution control.
Secure file sharing and clear technical
alignment
Identify risks earlier
Plan with clearer cost and lead time visibility
One-stop service, more consistent quality
Reliable delivery with full traceability
Explore how CNC Machining overcomes small-batch challenges, tight tolerances, and regulatory demands in medical manufacturing.
A practical guide to accelerating medical device development—from design verification & validation to production transfer under ISO 13485.
Discover the 4 critical factors that ensure safe, compliant, and production-ready medical injection molded components.
