Avrio Biopharmaceuticals Receives ISO 13485:2003 Certification for Medical Device Manufacturing
10/29/2010 6:58:29 AM
IRVINE, Calif., Oct. 28 /PRNewswire/ -- Avrio Biopharmaceuticals, LLC, a premier pharmaceutical manufacturing and development organization is pleased to announce it received the certification for ISO 13485:2003. This certification is a testament to the stringent quality systems and ever expanding service offerings here at Avrio. With this certification, Avrio achieves and exceeds the requirements set forth in ISO 13485 for a comprehensive management system for the design and manufacture of medical devices.
"Based on the needs and requests of our clients, Avrio has grown tremendously as a company in order to meet our client's expectations for ISO certification.," said Yvonne Verburgt, Vice President of Business Development. "Being ISO 13485 certified validates our facility design, quality systems, and procedures for the design and manufacturing of medical devices."
The certification for ISO 13485:2003 assures that Avrio meets the regulatory requirements of 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
"The goal at Avrio is to continue to grow with our current and prospective clients, as well as the industry as a whole," says Yvonne Verburgt. "How you successfully meet your clients' needs is what really sets you a part from the rest. We are pleased to have our expertise validated in this arena and look forward to many further expansions of our service capabilities."
To learn more about how Avrio is growing to meet client requirements for high quality manufacturing and development services, visit www.avriobiopharma.com or call: 866-98-AVRIO.
About Avrio Biopharmaceuticals, LLC
Avrio Biopharma, an affiliate of Irvine Pharmaceutical Services, is a premier contract manufacturing lab providing support to the pharmaceutical, biopharmaceutical, and medical device industries. Avrio, along with its Irvine affiliate, offers full cGMP product development support, specializing in preformulation/formulation, analytical development, process validation, aseptic filling, scale-up studies, packaging and labeling, stability testing and complete analytical CMC testing. Learn more at www.avriobiopharma.com or call 866-98-AVRIO (866-982-8746).
SOURCE Avrio Biopharmaceuticals, LLC