Medical Devices

Medical Device Components.
Precision-Made in Vietnam.

Surgical instruments, implant components, diagnostic housings, and disposable device parts โ€” manufactured to medical-grade tolerances at 40โ€“60% lower cost than US or European suppliers.

ISO 13485-capable factories ยท FDA documentation support ยท Full traceability

Why Source Medical Components from Vietnam?

The medical device industry faces relentless cost pressure โ€” from hospital procurement budgets to insurance reimbursement rates. Meanwhile, precision requirements keep increasing. Vietnam offers a way out of this squeeze: world-class machining capability at dramatically lower costs, without the IP risks and tariff headaches of China.

Vietnam's manufacturing sector has been quietly building medical device competency for over a decade, driven by Japanese and Korean medtech companies that moved production there ahead of Western firms. Today, Vietnamese factories machine surgical-grade stainless steel and titanium to the same tolerances as European job shops โ€” at a fraction of the cost.

DEWIN's role: we've already identified and audited the factories with medical-grade capability. We manage the entire supply chain from RFQ to delivered parts โ€” including the documentation trail that FDA and ISO 13485 require.

Medical Applications We Serve

๐Ÿ”ช Surgical Instruments

Forceps, retractors, clamps, scissors, needle holders. CNC machined from 17-4 PH and 440C stainless with passivation finishing.

Processes: CNC milling, turning, grinding, passivation

๐Ÿฆด Orthopedic Components

Bone plates, screws, spinal fixation rods, and instrument trays. Machined from Ti-6Al-4V and surgical-grade stainless to ยฑ0.005mm.

Processes: 5-axis CNC, Swiss turning, surface finishing

๐Ÿ”ฌ Diagnostic Equipment

Housings, brackets, chassis, and structural components for laboratory and point-of-care devices. Sheet metal and CNC machined.

Processes: Sheet metal, CNC machining, powder coating

๐Ÿ’‰ Disposable Device Parts

Injection-molded components for single-use devices: syringe barrels, catheter connectors, device housings in medical-grade PC, PP, and ABS.

Processes: Injection molding, cleanroom assembly

โš™๏ธ Endoscopy Components

Precision-turned shafts, housings, and articulation mechanisms for endoscopic instruments. Tight tolerances on small-diameter parts.

Processes: Swiss turning, micro-machining, electropolishing

๐Ÿฆท Dental Components

Implant abutments, instrument components, and custom prosthetic parts. CNC milled from titanium and zirconia with mirror finishes.

Processes: 5-axis CNC, micro-milling, polishing

Quality & Regulatory Compliance

Medical device manufacturing demands rigorous quality systems. Our partner factories provide the documentation and process controls your regulatory team requires.

Quality Systems

  • โœ“ ISO 13485-capable quality management
  • โœ“ ISO 9001:2015 certified factories
  • โœ“ GMP-compliant manufacturing areas
  • โœ“ Statistical process control (SPC)
  • โœ“ Documented CAPA procedures

Documentation

  • โœ“ Device History Records (DHR)
  • โœ“ First Article Inspection (FAI) reports
  • โœ“ Material certifications & traceability
  • โœ“ CMM inspection reports with GD&T
  • โœ“ IQ/OQ/PQ validation support

Medical-Grade Materials

Titanium

Grade 2 (CP) ยท Grade 5 (Ti-6Al-4V) ยท Grade 23 (ELI)

Surgical Stainless

316L ยท 316LVM ยท 17-4 PH ยท 440C ยท 304

Cobalt Chrome

CoCrMo (ASTM F75 / F1537)

Medical Plastics

PEEK ยท Ultem ยท Medical PC ยท USP Class VI resins

Aluminum

6061-T6 ยท 7075-T6 (device housings & fixtures)

Specialty

Nitinol ยท UHMWPE ยท Ceramic (zirconia, alumina)

Cost Comparison: Vietnam vs US & China

Component US China + Tariff Vietnam
SS316L surgical instrument (qty 200) $65โ€“90 ea $32โ€“42 ea $22โ€“30 ea
Ti-6Al-4V bone plate (qty 100) $180โ€“250 ea $90โ€“120 ea $60โ€“85 ea
Injection mold for device housing $45,000โ€“80,000 $12,000โ€“20,000 $8,000โ€“15,000
Aluminum diagnostic chassis (qty 500) $35โ€“50 ea $16โ€“22 ea $10โ€“15 ea

Indicative pricing based on typical complexity. Get an exact quote for your specific parts.

Our Process for Medical Components

1

Technical Review & Factory Selection

We review your drawings, material specs, and compliance requirements. We match you with the factory in our network that has the right equipment, certifications, and experience for your specific component.

2

Quotation & DFM Analysis

Detailed pricing with DFM recommendations within 48 hours. We'll flag any manufacturability issues and suggest design optimizations that maintain function while reducing cost.

3

First Article & Validation

First article samples with full FAI reports. We support IQ/OQ/PQ validation if required. No production begins until you approve the first articles.

4

Production & Delivery

In-process QC at every stage. Final CMM inspection with full documentation package. DDP delivery to your facility with complete traceability records.

Ready to Reduce Your Medical Component Costs?

Send us your drawings and compliance requirements. We'll match you with the right factory and return a detailed quote within 48 hours.

Get a Medical Parts Quote โ†’

Or email directly: leeloo@dewintech.com