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.
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CONTACT: Bio-AMD, Inc.
Tom Barr, CEO
+44 (0)8445 861 910