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Adoption of ISO Standard will help the company further “Raise the Bar” on producing high quality components for medical devices

Morgan Technical Ceramics’ Alberox business (MTC Alberox), a world leader in the manufacture 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. With MTC Alberox's strong technical background in applications engineering and tight process controls, this certification will enable the company to “raise the bar” in producing high quality critical components for the company’s extensive medical customer base.

The entire Medical Products Business Unit will be encapsulated in a class 100,000 cleanroom. This will enable MTC Alberox to effectively implement and maintain GMP (Good Manufacturing Processes) throughout the facility.

The ISO 13485:2003 standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). While it remains a stand-alone document, ISO 13485:2003 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 only requires the company to demonstrate that the quality system is implemented and maintained.

“This new ISO certification is a significant milestone in the advancement of our medical device business,” said 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.”

MTC Alberox continuously works to develop the most innovative and efficient solutions for the most challenging fields. With decades of experience in the fields of ceramic-to-metal assemblies, MTC Alberox engineers solutions for applications in markets that include medical, telecommunications, aerospace, electrical and power, and semiconductor and laser.