MEDFORD, Mass., Nov. 19 /PRNewswire/ -- Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial platforms for tissue regeneration, today announced that it has received ISO 13485:2003 certification, meeting stringent international quality standards required for medical device manufacturers. ISO certification is the standard recognized and accepted by most regulatory bodies worldwide as proof of an effective quality system. The company's lead product, the SeriACL(TM), is currently in clinical development as a biocompatible and biodegradable ligament graft, for repair of the anterior cruciate ligament (ACL).
"Receiving ISO certification is a significant milestone for our company, and demonstrates our firm commitment to quality systems in the manufacture of our products," said Gregory H. Altman, Ph.D., President and CEO, Serica Technologies. "With this certification, Serica has taken another important step forward in establishing our company as the leader in silk-based biomaterial platforms for tissue repair."
This international standard specifies requirements for a quality management system wherein a company must demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. "Certification is mandatory for regulatory approval of medical devices in many countries, and an important step towards our goal to commercialization in Europe," said Constance Garrison, Vice President, Regulatory Affairs and Quality Assurance, Serica Technologies.
Serica Secures $6 Million in New Financing
The company also announced today that it has closed on $6 million of additional funding, supported by existing investors, Morningside Technology Ventures, Prism VentureWorks and Ivy Capital Partners. The company has now raised a total of $23.5 million since its inception in 1998.
|SOURCE Serica Technologies, Inc.|
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