Entries in iso (4)


Colder Achieves ISO 13485 for Medical Devices

Colder Products Company, the leader in connections for medical devices, announces the successful certification of its ISO 13485:2003 Quality Management System. This certification confirms that Colder connectors are designed and manufactured to the highest standards of the medical device market.


“We continually seek opportunities to improve our products and processes to exceed our customers’ demands for high quality medical connectors,” states Gary Rychley, president of Colder Products Company. “ISO 13485 certification reinforces our commitment to the medical device market and to partnering with manufacturers to rapidly deliver new devices to market.”


Globally, there is an intensifying effort to harmonize the quality systems of medical device manufacturers, and ISO 13485 has been selected as the foundation for quality system compliance. ISO 13485 is a certification specifying international requirements on the ability to continuously provide medical devices and related services to meet regulatory and customer requirements. ISO 13485 certified suppliers can help medical device manufacturers get their devices approved and into production more rapidly.



Zenpure achieves ISO 9001, 13485, and 14001 certification

ZenPure is now ISO 13485,  9001, and 14001 certified.
ISO 9001 is the internationally recognized standard for the quality management of businesses.
ISO 14001 is the internationally recognized standard for the environmental management of businesses.
ISO 13485 is an ISO standard, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices



Bay AT earns ISO 13485 rating


Bay AT earns ISO 9001 rating