Company with Innovative Biomaterial Technology Achieves Significant Milestone in CE Mark Approval Pathway
FREMONT, Calif., June 15 /PRNewswire/ -- Biomerix Corporation, a medical technologies company developing products using its novel Biomerix Biomaterial™, a three-dimensional scaffold for biointegrative tissue repair, announced today that it has received an ISO 13485 Certificate of Registration. Issued by the British Standards Institution (BSI), the certification indicates that Biomerix has successfully implemented a quality system that conforms to the exacting International Organization for Standardization (ISO) standards for medical devices. ISO is one of the key regulatory requirements for a CE Mark in the European Union as well as other international markets. The certification applies to the Fremont, CA location which designs, manufactures and distributes finished medical devices and the Somerset, NJ location which manufactures the Biomerix Biomaterial.
ISO 13485 is an internationally recognized standardization system which defines standards for the design, development, production and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective devices. Achievement of ISO 13485:2003 demonstrates Biomerix Corporation's dedication to continuously improve product quality by providing finished medical devices and polymer components that consistently meet customer and regulatory requirements.
"This certification represents a major milestone for Biomerix Corporation and demonstrates our unwavering commitment to producing high-quality devices for our customers. Meeting the ISO standards speaks to our belief in our quality management system and is an important step towards commercialization abroad," commented Kenneth G. Hayes, President and Chief Executive Officer of Biomerix Corporation.
About Biomerix Corporation
Biomerix Corporation develops and manufactures a broad portfolio of implantable medical devices based on its proprietary Biomerix Biomaterial(TM) platform technology. Constructed as an ideal biointegrative scaffold, the Biomerix Biomaterial supports tissue repair and regeneration, leading to better clinical outcomes. Biomerix strives to improve patient outcomes through the development of medical devices for soft tissue repair, neurovascular embolization, spine annular repair, cardiovascular repair and women's health indications, utilizing its innovative Biomaterial.
For more information call 888.308.3620 or visit www.biomerix.com