Operating from an 18,000 sq ft state-of-the-art facility, inaugurated in 2013, we ensure excellence and compliance at every step of production. Our facility is not only ISO 13485:2016 certified with design but also 21 CFR 820 compliant and FDA registered, signifying our commitment to global quality standards. Specializing in a variety of materials such as titanium, cobalt chrome, stainless steel, PEEK, and thermoplastics, we employ advanced manufacturing technologies. These include multi-axis CNC turning, milling, wire EDM, ultrasonic washing with pharma grade water, laser marking, and proprietary surface finishing. Our comprehensive capabilities extend from prototyping to full-scale production, supported by rigorous QC vision systems and lights-out manufacturing. At Royal Oak Medical, we pride ourselves on our in-house design, engineering, and consulting services, creating bespoke solutions for implants, FDA 510K approved devices, and components—all tailored to meet the unique needs of our clients.