PDCI Medical Achieves ISO 13485 Certification for Medical Devices
Hayward, CA, February 10, 2011-PDCI Medical, leader in custom converting solutions
for the medical device industry, announced today that it has achieved ISO 13485
Certification.
ISO 13485 is a globally recognized quality standard for the design, development,
production and sale of medical devices. To be certified, organizations must demonstrate
an ability to provide medical devices and related services that consistently meet industry
regulatory requirements.
"Even before receiving certication, our company always adhered to the guidelines for
medical device development set forth by the International Standards Organization," said
Mike Behnam, PDCI's President. "We now have established a quality management
system that demonstrates its ability to meet the stringent requirements of our medical
customers. We can ensure these components are manufactured in accordance with the
most globally recognized quality management system and comparable to those made
by leading medical device manufacturers of the world."
"This ISO 13485 certification is the next logical step in PDCI's growth as a company,"
said Ron Tripp, Quality Manager. " In addition to validating our quality system and
practices, it will allow our customers to streamline their auditing processes when
selecting a medical device development partner. ISO 13485 isn't a goal for PDCI, it is a
starting point. It is the way we have always done business."
About PDCI Medical
PDCI Medical, a division of Pacific Die Cut Industries is a contract manufacturer
specialized in high precision clean room and dry room converting of non-rigid and
cellulosic materials and membranes, providing innovative subcomponents for both therapeutic and diagnostic devices in the cardiovascular, neurological, orthopedic, imaging and glucose monitoring markets. The company, founded in 1989, specializes in precision die cutting, narrow width slitting and multi-layer laminations. Value added services include: assembly, packaging, engineering, prototyping and project management.
PDCI Medical's offices and manufacturing facilities are located in Hayward, California. For more information, please visitwww.pacificdiecut.com.
