Orchid Keller Receives ISO-13485 Certification, Making All Orchid Orthopedic Divisions ISO-certified
September, 2008

TORRANCE, CA, September, 2008 – Orchid Keller, a division of medical device contract manufacturer Orchid Orthopedic Solutions, today announced it had received its ISO 13485: 2003 certification. ISO 13485:2003 is the quality requirements that medical device manufacturers must incorporate in their management systems for certification. It includes an emphasis on meeting regulatory as well as customer requirements, establishing risk management procedures, and maintaining effective processes specific to the safe design, manufacture and distribution of medical devices. With Orchid Keller’s certification, all Orchid Orthopedic divisions are ISO 13485:2003-certified.

In business for over 30 years, and exclusively dedicated to medical devices for the last 10 years, Orchid Keller’s expertise is in the area of large production machining. The company specializes in machining for orthopedic applications, including intramedulary nails, bone screws and plates for trauma and spinal applications.

According to Steve Dragovich, General Manager of Orchid Keller, the recent ISO certification is the final manifestation of the company’s ongoing dedication to quality. “Quality has been the bedrock of Orchid Keller since 1977. It’s a tradition that’s proved to be a key component of both our success and the satisfaction of our customers.”

ISO (International Organization for Standardization) is the world's largest developer and publisher of international standards for both the public and private sectors.