Medical Manufacturing Excellence

Precision-engineered medical devices, surgical instruments, and implantable components. ISO 13485 certified facility with Class 7 & 8 cleanrooms in Hawaii, USA.

FDA Registered | 21 CFR Part 820 Compliant

Orthopedic Implants

Titanium, PEEK, and cobalt-chrome spinal cages, hip stems, trauma plates. 5-axis CNC + additive manufacturing with micron-level precision.

Surgical Instruments

Precision stainless steel forceps, scalpels, retractors, and robotic surgery tooling. Laser marking and passivation available.

Drug Delivery Systems

Auto-injectors, pen needles, inhaler components. High-volume injection molding & automated assembly in cleanroom environment.

Wearable Medical Tech

Custom enclosures, biosensor housings, ECG patches, and IoT-enabled diagnostic devices with IP-rated sealing.

Dental & Craniomaxillofacial

Patient-specific implants, surgical guides, and CAD/CAM prosthetics using medical-grade resins and titanium.

Diagnostic Components

Microfluidic cartridges, assay housings, and point-of-care test device manufacturing with precision molding.

Advanced Medical Manufacturing Capabilities

Cleanroom ManufacturingISO Class 7 (10,000) & Class 8

Precision Machining+/- 2µm tolerance | Swiss CNC | 5-axis

Injection Molding30-500 ton presses, cleanroom molding

Additive ManufacturingMedical-grade PEEK, titanium, biocompatible resins

Assembly & PackagingSterile barrier systems, Tyvek sealing, EtO sterilization ready

Quality TestingSEM, CMM, tensile testing, accelerated aging

Regulatory Excellence

Full traceability from raw material to finished device. IQ/OQ/PQ validated processes.

FDA 510(k) Support

Statistical Process Control

UDI Compliance

Design History File (DHF)

Partner with Oloan Medical

From prototyping to full-scale production — we support OEMs, startups, and global medtech leaders.

500+

Medical devices manufactured in 2025

35+

Global medtech partners

99.8%

On-time delivery rate