SynGen Inc. Receives ISO 13485 and CE Mark Certification
11/30/2012 9:15:16 AM
SACRAMENTO, Calif., Nov. 30, 2012 /PRNewswire/ -- SynGen Inc., a company focused on the development and commercialization of medical systems that harvest stem and progenitor cells, from cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has achieved two key regulatory milestones. The Company was awarded an ISO 13485:2003 Certificate of Registration and a Full Quality Assurance certificate by the British Standards Institution (BSI), which allows it to CE Mark its own Class 1 products.
About ISO certification
ISO 13485:2003 is an internationally recognized standardization system for the design, development, manufacturing and distribution of medical devices. The certification confirms that SynGen has successfully implemented a quality system that conforms to the exacting standards of the International Organization for Standardization (ISO) standards for medical devices.
About CE Mark
SynGen also received CE Mark from BSI that allows SynGen to begin marketing its SynGenX-1000 Platform devices for the processing of cord blood in the European Union (EU). A CE Marking is a European marking of conformity that indicates a product complies with the essential requirements of the applicable European laws or directives with respect to safety, health, environment and consumer protection. The CE Marking is required on products in the countries of the European Economic Area (EEA) to facilitate trade among the member countries. The CE Marking provides a means for a manufacturer to demonstrate that a product complies with a common set of laws required by all of the countries in the EEA to allow free movement of trade within the EEA countries.
In addition to ISO Certification and CE Mark milestones, SynGen has also filed a 510(k) submission with the FDA for the clearance of the SynGenX-1000 platform products to process cord blood for the US marketplace, and that submission is pending with the FDA. These products harvest and cryogenically freeze stem and progenitor cells from collected units of placental/umbilical cord blood. These cells may be used later to reconstitute the hematopoietic system of patients afflicted with hematologic malignancies, like leukemia and lymphoma, and more than 70 genetic diseases.
Philip Coelho, SynGen's CEO noted that "We are very proud and excited about our achievement of these two key regulatory milestones, ISO 13485:2003 and CE mark certification. This accomplishment required the total dedication of every employee in the company but I especially want to praise Dr. Prince Emmanuel, our Vice President of Research & Development whose leadership and dedication to capturing every detail made it possible. Shaping our business practices to remain in full compliance with these regulations will demonstrate SynGen's dedication to continuously improve product quality by providing finished medical devices that consistently meet and exceed customer and regulatory requirements. This quality and regulatory milestone demonstrates that the systems and processes we have implemented at SynGen are effective to take this unique technology through product development and manufacturing into the marketplace."
SynGen Inc. enables regenerative cures through innovative engineering. The company invents and commercializes products that utilize single-use sterile plastic cartridge disposables mated to dedicated, highly automated electromechanical medical devices to isolate and capture stem and progenitor cells from peripheral and umbilical cord blood, bone marrow, RIA effluent and adipose tissue. Our products provide an important enabling platform for use in diagnostic, research, and clinical processes. Our inventions are based upon interdisciplinary fields that apply principles of engineering and life sciences to develop solutions required for regenerative medicine. For more information browse http://syngeninc.com/
SOURCE SynGen Inc.