This month, Diagnostics For All (DFA) celebrated a new achievement with their Liver Function Test (LFT): receiving certifications for ISO 13485:2013 in both Canadian and UK markets.
The International Organization for Standardization (ISO) creates independent, voluntary standards against which a manufacturer evaluates his/her Quality Management System (QMS). Certification ensures that certain global standards are being met and that products going to market are regulated and managed for quality. In particular, the ISO 13485 evaluates the QMS of medical devices entering market. For many markets across the globe, the ISO 13485 meets all the regulatory requirements for QMS; in fact for some, the ISO is the de facto standard for their quality management. These two certifications are necessary for DFA to bring their LFT product to the US, Canadian, and European markets.
The ISO certification marks a major milestone for DFA and the LFT project. It is a product of many hours working to implement a QMS that will ensure devices manufactured by DFA are safe and effective in various markets worldwide.
The LFT project continues to move through various regulatory bodies as it prepares for its next stages and, eventually, global use. Nonetheless, accessing these markets is an invaluable first step in reaching our target global audience. The additional revenue streams available in larger markets can one day subsidize DFA’s diagnostics so that they reach markets and, most importantly, people in developing countries.
About Diagnostics For All
Incorporated in 2007, Diagnostics For All is a 501(c)(3) non-profit enterprise creating low-cost, easy-to-use point-of-care diagnostics specifically designed for the developing world. These devices are elegantly simple and inexpensive. They require minimal training to use, minimal sample preparation, and no electricity or additional equipment. For more information, visit www.dfa.org or email info@dfa.org.