Precision CNC Machining for Medical Devices | ISO 13485 Certified

PROFIT Precision is ISO 13485:2016 certified for the manufacture of medical device components. We operate under a comprehensive quality management system aligned with 21 CFR Part 820 requirements, including document management, corrective actions, and design controls. Our facility maintains full material traceability from incoming raw material to finished part, with lot control and batch records for every production run. We provide Material Certificates, Certificates of Compliance, and upon request, process validation documentation including IQ/OQ/PQ for critical medical manufacturing processes.

We machine a comprehensive range of medical-grade materials including stainless steel 316L and 17-4 PH, titanium Grade 2 and Grade 5 (Ti-6Al-4V), aluminum 6061 and 7075, cobalt chrome, and medical-grade engineering plastics. Our plastic capabilities include PEEK (virgin and glass-filled for implantable devices), PTFE for catheter components and seals, POM/Delrin for instrument handles, polycarbonate for diagnostic housings, and medical-grade ABS for prototypes. All materials are sourced from certified mills with full mill test reports and documentation for regulatory submission.

Yes. PROFIT supports the full medical device development lifecycle from rapid prototyping to high-volume production. For design validation and clinical trial components, we offer accelerated turnaround of 3 to 5 business days with DFM feedback within 24 hours. Once designs are finalized, we scale into validated production with complete process documentation. Low-to-medium volumes ship within 7 to 10 days, while high-volume production runs execute within 15 to 25 business days with SPC monitoring and full lot traceability.

Material traceability is foundational to medical device quality. PROFIT operates strict lot control procedures: every material batch from certified mills is logged with unique lot and heat numbers, with accompanying mill test reports documenting chemical composition and mechanical properties. This traceability data links to each production order and is maintained in batch records for regulatory review. For implantable components, we offer independent material spectrometry analysis and process validation documentation. The complete traceability chain from raw material lot number to finished part serial number is documented with each shipment.

Yes. PROFIT has extensive experience machining components for surgical instruments and implantable medical devices. We manufacture surgical instrument handles and tips from stainless steel and titanium, orthopedic implant trials for knee, hip, and spinal applications, and custom instrument trays for sterilization. These components require tight tolerances of ±0.03mm or better, surface finishes of Ra 0.8 for tissue contact, and burr-free edges for patient safety. Our 5-axis DMG MORI centers and CMM inspection ensure every component meets print specifications.

Every medical component shipment includes a Certificate of Compliance (CoC) with lot number and batch records. Additional documentation available upon request: Material Certificates with mill test reports, First Article Inspection (FAI) reports with dimensional data, CMM inspection reports for all critical features, process validation documentation (IQ/OQ/PQ), and packaging verification for sterility compatibility. Our quality team maintains complete batch records for each production order, ensuring full traceability and regulatory compliance for Class I, II, and III medical devices.