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Grace Wins Medical Device Certification

W R Grace & Co has earned an additional certification for the Quality Management System at its facility in Hesperia, California. The ISO 13485:2003 certification was issued by SGS, a provider of certification and testing services, for Class I medical devices manufactured at Hesperia.

Grace said that Hesperia joins four other Grace facilities that were previously certified to the ISO 13485:2003 standard for medical devices: Epernon, France (certified in 1997); Chicago, Illinois (certified in 2004); Surat, India (certified in January 2009) and Deerfield, Illinois (certified in March 2009). Pursuing each certification was a proactive and voluntary decision by Grace in an effort to test the company’s quality management systems.

Grace said that the current certification is the second one focused on the pharmaceutical industry that Grace has earned in 2010. In March, Grace successfully garnered an Excipient Good Manufacturing Practices (GMP) certification of its quality management system in Baltimore, Maryland.

That particular certification verified that Grace’s Quality Management System met the requirements of the Joint International Pharmaceutical Excipients Council Pharmaceutical Quality Group GMP Guide for Pharmaceutical Excipients. Pharmaceutical excipients are inactive ingredients (additives) used in drug formulations.

Greg Poling, vice president of WR Grace & Co and president of Grace Davison, said: “Our customers can be confident that, with Grace Davison, they are receiving premiere quality products which help pharmaceutical and biotechnology companies develop drugs more rapidly and efficiently.”