Advanced Materials Inc. Achieves ISO 13485 Certification
15 August 2007 - 5:50PM
Business Wire
Advanced Materials Inc. (AMI) (Pink Sheets:ADMG) announced today
that it has successfully achieved ISO 13485 certification, which
signifies the positive assessment of the company�s medical device
quality system. As a leading manufacturer of medical device
products, the announcement presents a significant opportunity for
the company to increase growth and value by conquering the global
market and bringing its products to the forefront of international
recognition. The accomplishment is also important for the medical
device industry, which is dependent on the quality and credibility
of its manufacturers and their products for its continued
development. �AMI�s involvement and leadership in the medical
device industry is critical for the growth of the company as well
as the industry as a whole,� said Celinda Solano, director of RA-QA
and product development for AMI. �This certification not only
solidifies AMI�s position as a leading developer and manufacturer
of medical, consumer and industrial products, but also proves the
company�s value-driven commitment to its shareholders and
customers.� As a supplement to the ISO 9001, the ISO 13485 is an
international standard that represents the requirements of a
comprehensive management system for the design and manufacturing of
medical products. Some of the additional requirements relate to
design controls, process controls, special processes, traceability,
record retention, and regulatory actions. Compliance with the ISO
13485 is often seen as a company�s first initiative to meet
European regulatory requirements. The result of a positive
assessment of a medical device quality system is the authorization
of the CE-Identification and permission to sell these products in
the European Union. About Advanced Materials, Inc: Dallas�based
Advanced Materials, Inc. (AMI) is a leading developer and
manufacturer of medical, consumer and industrial products for some
of the top Medical OEM�s in the country. Since its reinvention in
2005 under President and CFO William Mortensen, AMI has increased
shareholder value by developing and selling proprietary and
patented products, all while maintaining customer satisfaction.
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