Bio-AMD, Inc.; Implementation of ISO9001 and ISO 13485 Quality Standards
London, England May 21, 2015; Bio-AMD, Inc. and Bio Alternative Medical Devices Ltd., our majority owned medical devices subsidiary (together Bio-AMD, We or the Company OTCQB: BIAD) is pleased to announce that it is to formalise implementation of the International Organisation for Standardization quality standards ISO 9001:2008 and ISO 13485:2012.
The Company, which already works to the requirements of these standards, has engaged a specialist ISO quality standard consultancy to provide support for this implementation as we move through our technology commercialization process.
ISO 9001 is the world’s most popular quality management system framework. More than a million organisations in over 175 countries are certified to its requirements. The standard’s focus is on the use of planning to drive success through improved customer satisfaction, motivation of personnel and continual improvement.
ISO 13485 is the preferred management system for the quality control of medical devices. The standard ’tunes’ the fundamental requirements of ISO 9001 to provide a management framework for the design and production of medical devices and in-vitro diagnostic devices. ISO 13485 is an essential requirement for the mandatory CE conformity marking of medical devices manufactured in or designed to be sold in the European Economic Area.
Registration of devices to both the above standards will also provide a robust platform from which to apply for regulatory approval for the Company’s technologies in non-European markets, such as from the U.S. Food and Drug Administration.
Dr Djennati, Managing Director of Bio Alternative Medical Devices Ltd., said: ‘ISO 9001 and ISO 13485 are the primary international quality standards applicable to med-tech companies. Registration will provide our partners and customers assurance that our products have been through a rigorous quality process that will continue well beyond a product launch. We are confident that we will achieve registration to both ISO standards, which will further enhance our reputation in the healthcare sector.’
About Bio-AMD, Inc.
Bio-AMD has two majority owned UK subsidiaries: Bio-AMD Limited, a technology developer for medical diagnostic devices; and WOCU Ltd, the owner of the WOCU®, a global currency data reference source for application in financial markets. (www.wocu.com).
To find out more about Bio-AMD (OTCQB: BIAD), visit our website at www.bioamd.com.
Statements in this news release that are not statements of historical fact are forward-looking statements, which are subject to certain risks and uncertainties. Forward-looking statements can often be identified by words such as “expects”, “intends”, “plans”, “may”, “could”, “should”, “anticipates”, “likely”, “believes” and words of similar import. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Actual results may differ materially from those expressed or implied by forward-looking statements due to a variety of factors that may or may not be foreseeable or within the reasonable control of the Company. Readers are cautioned not to place undue reliance on such forward-looking statements. Additional information on risks and other factors that may affect the business and financial results of the Company can be found in filings of the Company with the U.S. Securities and Exchange Commission, including without limitation the section entitled Risk Factors in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 filed on March 30, 2015, and in Company reports filed subsequently thereto. Except as otherwise required by law, the Company disclaims any obligations or undertaking to publicly release any updates or revisions to any forward-looking statement contained in this news release to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based..
CONTACT: Bio-AMD, Inc.
Tom Barr, CEO
+44 (0)8445 861 910