Engineered for Patient Safety & Regulatory Excellence

Medical manufacturing demands zero compromise. Our dedicated medical division combines advanced CNC machining, precision forming, and cleanroom assembly with rigorous quality management systems to deliver components that meet the strictest global standards.

  • ✅ 100% material traceability & lot tracking
  • ✅ DMR/DHR documentation & audit readiness
  • ✅ Sterilization compatibility (EtO, Gamma, Radiation)
  • ✅ Biocompatibility testing & certification support
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Dedicated Medical Facility

Segregated cleanroom environment with HEPA filtration, ESD control, and strict particulate monitoring to prevent cross-contamination.

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Precision Processes for Medical Applications

End-to-end production tailored to medical device lifecycles.

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5-Axis CNC Machining

Tight tolerance machining (±0.002mm) for complex geometries in titanium, stainless steel, and cobalt-chrome alloys.

Electropolishing & Passivation

Surface finishing to Ra 0.2µm with full passivation per ASTM A967 to ensure corrosion resistance and biocompatibility.

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Cleanroom Assembly

ISO Class 7 assembly with lint-free garments, ionization bars, and controlled humidity for sensitive components.

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CMM & Optical Inspection

100% inspection with GD&T reporting, first article inspection (FAI), and SPC data logging for regulatory submission.

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Sterile Packaging

Medical-grade blister packs, Tyvek pouches, and double-bagging with sterilization indicators and expiry dating.

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Material Certification

Raw material traceability with mill test reports (MTR), heat lot tracking, and RoHS/REACH compliance documentation.

Biocompatible & Implant-Grade Alloys

Titanium & Titanium Alloys

Excellent strength-to-weight ratio and osseointegration properties for orthopedic and dental implants.

Ti-6Al-4V ELI Grade 23 Titanium Pure Titanium Grade 1/2

Stainless Steel

High corrosion resistance and formability for surgical instruments and temporary implants.

316L SS 17-4 PH MP35N

Cobalt-Chrome Alloys

Exceptional wear resistance and hardness for joint replacements and cardiac devices.

CoCrMo ASTM F75 ASTM F562

High-Performance Polymers

Lightweight, sterilizable plastics for housings, connectors, and non-implant components.

PEEK PEEK Delrin/Acetal Ultem

From DFM to Sterile Delivery

1

DFM & Review

Design for manufacturability analysis, tolerance stacking review, and material selection.

2

Material Verification

Certified raw material receipt, lot tracking, and incoming inspection per ASTM/ISO standards.

3

Precision Production

CNC machining, forming, or molding in controlled environments with full process parameter logging.

4

Validation & Release

FAI, CMM inspection, surface treatment verification, and DHR compilation for audit readiness.

Medical Manufacturing Specifications

ParameterSpecification
Tightest Tolerance±0.002 mm (0.00008")
Surface FinishRa 0.2µm (8 ºin) to Ra 3.2µm (125 ºin)
Part ComplexityMulti-axis geometries, micro-features, internal channels
Batch SizePrototype to 10M+ units with validated tooling
Inspection Rate100% for Class III devices; AQL sampling for Class I/II
DocumentationDMR, DHR, FAI, MTR, CoC, Sterilization Validation

Medical Manufacturing FAQ

What certifications does your medical facility hold?
We are ISO 13485:2016 certified and compliant with FDA 21 CFR Part 820. Our quality management system supports CE Mark (MDR) registration and USP Class VI biocompatibility testing.
Do you support sterilization validation?
Yes. We provide sterilization compatibility data for EtO, Gamma, and E-Beam processes, including pack testing, bioburden validation, and shelf-life stability studies.
How do you handle material traceability?
Every raw material lot is tracked from receipt through final packaging. We maintain heat/lot records, mill certifications, and provide full genealogy reports for audit and regulatory submission.
What is the typical lead time for medical prototypes?
Simple prototypes typically take 5-7 business days. Complex medical components with custom tooling or special surface treatments range from 10-14 days. We offer expedited services for urgent clinical trials.

Request a Medical Manufacturing Quote

Share your drawings, material requirements, and target volumes. Our medical engineering team will provide a detailed DFM review and competitive quote within 24 hours.

Dedicated Medical Liaison:

📞+1 (800) 555-METAL (ext. 4)
✉️medical@metalcore-mfg.com
🔒NDA & ITAR compliant on file