Facility Certified to ISO 9001, EN46001 and ISO 13485 Standards
SAN LUIS OBISPO, California – December 19, 2000 – FzioMed, Inc., the developer of Oxiplex™ technology, announced today it has received ISO 9001 certification. FzioMed’s Oxiplex™ technology is used to produce bioresorbable materials for surgical and medical applications.
FzioMed, Inc. has received certification from KEMA – Registered Quality, Inc. as compliant to ISO 9001, EN 46001 and ISO 13485 international standards. Certification of compliance with ISO 9001 is awarded to companies that meet or exceed quality standards for development and manufacturing of products set forth by the International Standards Organization (ISO). ISO 9001 is internationally recognized as the most comprehensive of the standards designed to measure the overall quality of a company’s design, development and manufacturing processes. EN 46001 and ISO 13485 are the applicable European and Canadian standards for quality systems and medical products.
“Certification to ISO quality standards is a key milestone for FzioMed,” said Tom Juarez, Director of Regulatory Affairs and Quality Assurance for the company. “This validates our uncompromising commitment to quality in the development and manufacture of Oxiplex™ medical products.”
Ronald Haynes, President and CEO of FzioMed, Inc. stated, “ISO certification is an important step in our global product development strategy. We are very proud of our team in achieving these prestigious quality certifications.”
FzioMed is a medical device company engaged in the development and manufacture of bioresorbable products based on the company’s patented Oxiplex™ technology. Oxiplex™ is a unique polymer technology that is formulated for a variety of targeted markets. Products in development using Oxiplex™ include those for the prevention of post-surgical adhesions, hemostasis during surgery, osteoarthritis and drug delivery. FzioMed products are at various stages of pre-clinical and clinical development, and are directed towards high growth markets in the rapidly growing field of biosurgery products.
Oxiplex™ is a registered trademark of FzioMed, Inc.