SEATTLE, WA--(Marketwired - Jun 25, 2014) - Atossa Genetics Inc. (
- ISO 13485:2003 "Medical devices - Quality management systems - Requirements for regulatory purposes"
- EN ISO 13485:2012 and AC:2012 (Canadian)
- ISO 9001:2008 "Quality managements systems - Requirements"
The International Organization for Standardization, or "ISO," is the world's largest developer of international standards which are recognized globally for their stringent criteria. ISO 13485 and 9001 requirements are among the most comprehensive of the approximately 19,000 standards established by the organization and serve as the model for quality management systems.
"We are very pleased to achieve these highly coveted registration certificates as we strive to deliver excellence in our quality management and practices, manufacturing policies, operational processes and our continuous improvement efforts," said Steven Quay, Chairman, CEO & President of Atossa. "We are proud of our entire staff for achieving this major milestone, as we continue to identify areas for improvement in our quality management system, operational processes, and overall product quality," he continued.
ISO 13485:2003, which is the most recent iteration of ISO 13485, is a comprehensive standard for establishing quality management systems for the design, development, production and manufacturing of medical devices. The "EN" designates a "harmonized standard", which means that the European Union has accepted this standard and it is a precursor to receiving certification under the European Medical Device Directives, Annex II. Atossa expects this EU certification to be complete in the next several weeks. ISO 9001:2008 specifies requirements for a quality management system where an organization demonstrates, among other things, its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.
The process of receiving certificates under ISO 13485 and 9001 required an evaluation of all aspects of Atossa's business processes and procedures to confirm conformity with the requirements outlined in these standards. Registration to these standards signifies that Atossa has implemented an integrative management system that complies with the applicable regulatory requirements for quality management.
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory developed tests (LDTs), medical devices and therapeutics. The Company's LDTs are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The LDT's and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For additional information, please visit www.atossagenetics.com.
Forward-Looking Statements
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, including timing of review by the FDA of 510(k) submissions, and actions related thereto, whether Atossa can submit additional information to the FDA in a timely fashion and whether the FDA will find that information acceptable and/or request additional information, the outcome of the FDA re-inspection completed on March 14, 2014, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa's products and services, performance of distributors, estimated future expenses and cash needs, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.