NEWS - CERTIFICATION FOR INTERNATIONAL DISTRIBUTION
Chromatics Color Sciences Receives Important ISO-9001 and EN46001 Quality Certifications Supporting International Distribution of Infant Monitoring Device
NEW YORK, March 22 /PRNewswire/ -- Chromatics Color Sciences
International, Inc. (Nasdaq: CCSI) today announced it has received the ISO-9001 and EN46001 certifications -- signifying that the Company's New York facility meets important international quality standards for product design, development, manufacturing, servicing and distribution.
The certifications, awarded by TUV CERT, the certification body of
Rhelnisch-Westralischer TUV e. V., recognize the Company's established quality system for the design, development, manufacturing, servicing and distribution of its Colormate(R) TLC-BiliTest(TM) System, a transcutaneous bilirubinometer, for monitoring infant jaundice.
In order to attain ISO-9001 and EN46001 certifications, a medical device company must successfully complete a third-party audit against the standards by an organization that has been accredited by a government entity in the European Union. CCSI underwent and passed such a comprehensive audit that was conducted by TUV Essen of Germany in November 1998, passed further product inspection in February 1999, and has now received its certifications.
Chromatics Chief Executive Officer Darby Macfarlane commented, "We are
extremely pleased to have obtained these certifications. It's a key step toward bringing our breakthrough product to doctors and babies in other countries. It also adds to customer confidence in our product here in the United States."
The Company previously announced that its contract manufacturer also has an ISO-9001 and EN46001-certified facility and that the Colormate(R) TLC-Bilitest(TM) System is manufactured by the Company's contract manufacturer in accordance with ISO-9001 and EN46001 regulatory standards and the U.S. Food and Drug Administration's (FDA) Quality System Regulation (QSR), which enumerates current good manufacturing practices governing the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices for U.S. distribution.
The device is currently being marketed and shipped to U.S. hospitals and physicians. The new certifications are a further important step in the Company's plans for international marketing and distribution of the System. ISO (International Organization for Standardization), headquartered in Geneva, Switzerland, is an internationally recognized standard-setting institution comprised of experts from over 90 countries, including the United States. The ISO-9000 series of standards addresses quality systems including quality management and quality assurance. ISO-9001 is the most comprehensive in scope of the ISO-9000 series standards.
EN46001 represents additional mandatory requirements for medical devices that were promulgated by a Committee for the European Union. Macfarlane said today, "We continue to move steadily forward with our business plan. Our U.S. roll-out that began last month is proceeding as planned, with initial distribution and in-servicing of the Colormate(R) TLc-BiliTest(TM) System to hospitals and physicians. We continue to receive positive feedback from doctors and neonatal nurses using the System."
The Colormate(R) TLc-BiliTest(TM) System (TLc for tender, loving care) is the only device marketed in the U.S. for pain-free, non-invasive monitoring of hyperbilirubinemia for babies of all races and all gestational ages -- even when undergoing phototherapy treatment. A study of the device published in Pediatrics, the publication of the American Academy of Pediatrics, found that Colormate(R) TLc-BiliTest(TM) System results correlate within a clinically useful range to results obtained from current invasive techniques that involve taking blood from infants -- often repeatedly.
Chromatics Color Sciences is in the business of color science and has
developed technologies and intellectual properties that it believes have medical applications involving monitoring of certain chromogenic diseases or disorders such as hyperbilirubinemia in newborns. The Company defines chromogenic diseases or disorders as those diagnosed or monitored by the coloration of the human skin, tissue or fluid being affected. Medical applications in addition to the monitoring of hyperbilirubinemia in newborns will require additional clinical trials and FDA clearances for commercial use.
The Company's technologies and intellectual properties also have other
applications including the scientific color measurement and classification of human skin and certain color-sensitive consumer products, and in determining the color compatibility of such skin and product color classification for use in a variety of industries including the cosmetic, beauty-aid and fashion industries.
Certain of the matters discussed in this announcement contain forward-
looking statements....... |
