Patient-specific. ISO 10993 materials. Clinically ready.

ISO 10993: international standard for biocompatibility testing of medical devices. Required for FDA submissions, CE marking. Comprehensive testing (cytotoxicity, sensitization, irritation, implantation). USP Class VI: United States Pharmacopeia classification. Older standard, still referenced but ISO 10993 is becoming universal. Both certify biocompatibility for specific uses. Specify which certification your application requires.

For patient-specific devices (surgical guides, anatomical models): typically Class I device, FDA 510(k) exempt. For implantable 3D printed devices (cranial plates, spine cages): Class II or III, 510(k) or PMA required. Manufacturing must comply with FDA 21 CFR Part 820 QSR, ISO 13485. We provide components under customer's QSR/ISO 13485 system — not manufacturers of complete medical devices ourselves. Our documentation supports customer QSR.

Typical workflow: (1) Customer provides CT or MRI imaging data. (2) Imaging segmented and processed into 3D model of anatomy. (3) Surgeon reviews and approves model/guide design. (4) 3D printing in appropriate biocompatible material. (5) Post-processing (support removal, sterilization). (6) Packaging with unique patient identifier. We support steps 4-6, typically working with customer or partner who handles steps 1-3.

Medical 3D printed parts must survive sterilization: autoclave (121 °C, 15 psi steam), gamma radiation, ethylene oxide (EtO). Compatibility: Ti, PEEK, 316L — all methods. Medical SLA resin: limited autoclave cycles, gamma OK. Medical PA12: gamma and EtO preferred over autoclave. Specify sterilization method — we select appropriate material and process.

Surgical guides from imaging: 5-7 days typical. Dental crowns: 1-3 days (standard production). Patient-specific implants: 2-4 weeks including design approval and regulatory process. For emergency cases (surgical rescheduling), rush turnaround possible. Documentation packages add 1-3 days.

Medical 3D printing documentation: material certification (lot number, biocompatibility certification), process record (machine, operator, parameters), post-processing record, quality verification, patient identifier (if patient-specific). We provide documentation package compatible with customer's ISO 13485 QMS. For traceability required long-term retention, records archived for specified period.