We are experts in developing products from concept to market, including validations, safety markings, and FDA 510(k) submissions. Nikao’s Engineering staff provides an extensive list of product design, development and validation services, which are performed under the guidance of our Quality Assurance and Quality Engineers who are experienced in working with the requirements of international, national and regional standards and regulations. Nikao can also assist our customers with their PMA, FDA 510(k) submissions and Quality Systems implementation.

In addition to all of the design and support services Nikao offers, the core competency of the company lies in the quality manufacturing of medical instrumentation and devices. It is the culmination of the services outlined above that make Nikao a true one-stop facility for companies looking for high quality design and manufacturing of medical products, devices, and related technologies. Please visit the Solutions section to review a complete list of all our capabilities.