Life-critical components engineered to the highest standards of biocompatibility, regulatory compliance, and microscopic precision. From prototyping to full-scale sterile production.
Integrated processes designed for regulatory submission, clinical validation, and high-volume sterile production.
ISO Class 7 & 8 cleanroom environments for sterile component assembly, preventing particulate contamination.
5-axis machining of surgical-grade metals with tolerances down to ±0.0005" for implants and instruments.
USP Class VI compliant polymers with validated cycle times, automated inspection, and batch traceability.
Medical-grade barrier packaging validated to AAMI TIR 12 and ISO 11607 standards for terminal sterilization.
Every process, material, and batch is documented to meet global medical device regulations.
QSR compliant manufacturing systems
Medical device quality management
Risk management for medical devices
Ce-mark ready technical files
Unique device identification labeling
Certified raw materials with full traceability and material certificates (CoC/MTC).
316L, 17-4PH, 440C for instruments & implants
Ti-6Al-4V ELI, Grade 5 for orthopedic & dental
ISO 10993 compliant engineering thermoplastics
From disposable diagnostics to implantable life-support systems.
Clamps, forceps, trocars, and endoscopic tools
Fixation plates, screws, joint replacement components
IVD cartridges, sensor housings, wearable devices
Rigorous testing and documentation at every stage to ensure patient safety.
Submit your requirements for a compliance-ready quote. Our regulatory & engineering teams will respond within 24 hours.