FAIRFIELD, NJ-Morgan Technical Ceramics’ Alberox business, manufacturer of ceramic-to-metal assemblies, has attained ISO 13485: 2003 certification. ISO 13485: 2003 represents the requirements for a comprehensive quality management system for the manufacture of medical devices. In order to achieve this certification, companies must demonstrate the ability to provide products and services that consistently meet customer and regulatory requirements.
The certification applies to the company’s Medical Implant Business Unit and its internally supplied ceramics department. The entire Medical Products Business Unit will be encapsulated in a class 100,000 cleanroom.
“This new ISO certification is a significant milestone in the advancement of our medical device business,” says Ken Camara, MTC Alberox sales manager. “More importantly, by acquiring this designation, our customers can be even more confident that our manufacturing practices adhere to the highest possible standards, and that they will be purchasing the highest-quality critical medical component products available.”
For more information, call (617) 367-0100 or visit www.morgantechnicalceramics.com