Product Description

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:

• Advanced CNC Machining: 3- to 5-axis milling/turning with ±0.005" tolerances.

• Material Expertise: ISO 13485-compliant biocompatible metals (e.g., 316L stainless, titanium) and engineering plastics (PEEK, Ultem).

• Digital Workflow: DFM analysis, automated programming, and real-time project tracking.

Post-Processing & Compliance:

• Surface Finishes: Electropolishing, anodizing, bead blasting, and ultrasonic cleaning.

• Sterilization-Ready: Passivation per ASTM A967, cleanroom packaging (ISO Class 8).

• Full Traceability: Material certs (RoHS, REACH), lot control, and ERP-managed documentation.

Cost Efficiency:

• EVT Prototyping: Rapid-turn (5-7 days), low-volume batches with zero tooling investment.

• PVT Scalability: Seamless transition to high-volume production with cost-optimized machining strategies.

Quality Assurance:

• In-Process Checks: First-article inspection (FAI), CMM verification, and PPAP documentation.

• Final Validation: 100% dimensional checks per ASME Y14.5, tensile testing, and leak tests.

• Regulatory Alignment: FDA 21 CFR Part 11-compliant documentation support.

Why Partner With Us?

• End-to-End Control: Single-source accountability from raw material to finished part.

• Risk Mitigation: Process validation (IQ/OQ/PQ) and PPAP submissions for FDA audits.

• 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.

 

Payment Terms︰ T/T, Alipay, Paypal, WeChat

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