FzioMed,
Inc. Achieves International Quality Certification
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.
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