MFGsourcing delivers certified CNC machining services tailored for medical device manufacturing, supporting every phase: Engineering Verification (EVT), Design Validation (DVT), and Production Validation (PVT).
Manufacturing Process:
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Advanced CNC Machining: 3- to 5-axis milling/turning with ±0.005" tolerances.
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Material Expertise: ISO 13485-compliant biocompatible metals (e.g., 316L stainless, titanium) and engineering plastics (PEEK, Ultem).
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Digital Workflow: DFM analysis, automated programming, and real-time project tracking.
Post-Processing & Compliance:
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Surface Finishes: Electropolishing, anodizing, bead blasting, and ultrasonic cleaning.
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Sterilization-Ready: Passivation per ASTM A967, cleanroom packaging (ISO Class 8).
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Full Traceability: Material certs (RoHS, REACH), lot control, and ERP-managed documentation.
Cost Efficiency:
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EVT Prototyping: Rapid-turn (5-7 days), low-volume batches with zero tooling investment.
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PVT Scalability: Seamless transition to high-volume production with cost-optimized machining strategies.
Quality Assurance:
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In-Process Checks: First-article inspection (FAI), CMM verification, and PPAP documentation.
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Final Validation: 100% dimensional checks per ASME Y14.5, tensile testing, and leak tests.
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Regulatory Alignment: FDA 21 CFR Part 11-compliant documentation support.
Why Partner With Us?
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End-to-End Control: Single-source accountability from raw material to finished part.
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Risk Mitigation: Process validation (IQ/OQ/PQ) and PPAP submissions for FDA audits.
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Sustained Support: Dedicated engineering team for design optimization and lifecycle management.
Accelerate your medical device development with precision-engineered components, manufactured under strict quality protocols and delivered with full regulatory transparency.
