Precision Manufacturing for
Medical Devices

Delivering biocompatible, ultra-precision components for implants, surgical instruments, and diagnostic equipment with full regulatory compliance and traceability.

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Engineered for Patient Safety & Regulatory Compliance

MetalCore's medical manufacturing division combines advanced machining with strict quality protocols to support medical device innovators. From early-stage prototyping to high-volume production, we ensure every component meets the rigorous standards required for human implantation and clinical use.

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ISO 13485 & FDA Registered
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Class 7 & 8 Cleanroom Assembly
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Full Material Traceability
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USP Class VI Certified Polymers & Metals
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Specialized Manufacturing Processes

End-to-end production support tailored for the medical device lifecycle.

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Micro & Precision Machining

5-axis CNC and Swiss-style turning for complex geometries with tolerances down to Β±0.002mm, ideal for orthopedic and cardiovascular components.

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Cleanroom Assembly

ISO Class 7/8 controlled environments for sterile packaging, sub-assembly, and final inspection with ESD-safe protocols.

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Medical Injection Molding

High-cavity tooling for biocompatible thermoplastics (PEEK, ULTEM, PTFE) with strict statistical process control.

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Surface Treatment & Coating

Medical-grade anodizing, electropolishing, PTFE coating, and hydrophilic treatments to enhance biocompatibility and performance.

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Quality & Validation

Full documentation including IQ/OQ/PQ, COCs, material certs, and first-article inspections per AS9102/ISO standards.

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Sterile Packaging & Logistics

Vacuum sealing, tyvek pouching, and barrier packaging compliant with ISO 11607, ready for global distribution.

Serving the Medical Device Ecosystem

Trusted by OEMs, startups, and contract manufacturers across critical medical sectors.

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Orthopedic & Implants

Joint replacements, bone screws, spinal cages, and fixation devices manufactured from Ti-6Al-4V and CoCr alloys.

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Surgical Instruments

Precision blades, trocars, graspers, and robotic-assisted surgery components with micro-tolerance finishes.

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Diagnostic & Monitoring

Housings, sensor mounts, and internal assemblies for MRI, ultrasound, and patient monitoring systems.

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Drug Delivery & Catheters

Micro-machined valves, syringe components, and catheter assemblies requiring ultra-smooth surface finishes.

Built for Regulatory Confidence

Every component is manufactured, inspected, and documented to meet the strictest global medical standards.

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ISO 13485:2016

Quality management system specifically designed for medical device manufacturing.

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FDA 21 CFR Part 820

Full compliance with U.S. federal regulations for medical device production.

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USP Class VI

Biocompatibility testing for plastics and elastomers in contact with tissue.

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Full Traceability

Lot-batch tracking from raw material receipt to final shipment documentation.

Ready to Advance Your Medical Device?

Submit your specifications for a detailed engineering review and transparent quotation within 48 hours.

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Speak with Our Medical Team

Our dedicated medical device engineers understand regulatory requirements, material selection, and production scalability. We'll help you navigate from concept to clinical release.

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Medical Hotline
+1 (800) 555-DOC
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Email
medical@metalcore-mfg.com
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Facility
Cleanroom Wing B, Detroit MI

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