March 15, 2013 - PrimaPharm, Inc., a contract manufacturer of drugs and medical devices, announces the successful completion of its ISO 13485:2003 recertification audit for its production facility located in San Diego, California. PrimaPharm has maintained its ISO 13485:2003 certification with the British Standards Institute since 2000, and the recently completed audit recertifies the company through 2016.
ISO 13485:2003 certifies that a quality management system has been established and maintained that is oriented specifically towards the design, development, production and installation of medical devices and related services. Certification requires the company to demonstrate its ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. ISO 13485 certification enables PrimaPharm to conduct business internationally in the highly-regulated sectors of the European Union, Canada, and other countries.
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