DOBI MEDICAL SYSTEMS AWARDED ISO 9001/EN ISO 9001/EN46001/CE MARK CERTIFICATIONS
MAHWAH, NJ, January 31, 2001. DOBI Medical Systems, LLC, developer of a new, angiogenesis based diagnostic system for non-invasive breast cancer detection, today announced that it has received ISO 9001, European Community EN ISO9001 and EN 46001 Certifications for its quality system at its headquarters facility in Mahwah, New Jersey. These certifications recognize the Company's process compliance with the highest and most comprehensive standards covering quality product design and manufacturing. For medical devices, EN 46001 Certification is awarded only to those companies that both satisfy ISO 9001 and comply with the European Union's Medical Device Directive. Additionally, DOBI Medical's Dynamic Optical Breast Imaging System was awarded the Registered CE mark from TUV, an accredited European Notified Body. The Company received these Certifications after rigorous onsite audits.
Obtaining the ISO 9001 and EN 46001 certifications demonstrates DOBI Medical's commitment to assuring quality excellence for the products it is developing utilizing its patented optical breast imaging technology. It also positions products from DOBI Medical Systems with other world-class manufacturers who demonstrate recognized quality and safety in compliance with related international standards for medical devices.
"We are pleased to announce the accomplishment of such an important milestone in our corporate development and recognize that these certifications represent the foundation for our overall quality effort," said Phillip C. Thomas, CEO of DOBI Medical Systems. "However, we will continue to refine and improve our quality program as an ongoing result of our dedication to excellence in all we do."
About DOBI Medical Systems
Except for historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In addition to the factors set forth above, other important factors that could cause actual results to differ materially include, but are not limited to, technical risks associated with new technology development, government regulatory approval, market acceptance of our product, competition and technological change.
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DOBI Medical International