Dear Co-Diagnostics shareholders,
We are excited to announce that we have received our official certificates for ISO 13485, the design and manufacture of medical devices (registration no. 10013216 MP23); and ISO 9001, the fundamental requirements of a Quality Management System (registration no. 10013216 QM08). The official press release can be found here: http://www.prweb.com/releases/2015/01/prweb12427674.htm
The International Organization of Standards, or ISO, is a non-government entity comprised of academic and industry professionals who certify that companies are compliant with industry-standard best practices in the production and operations. These ISO certifications are granted to DNA Logix Inc, now a wholly-owned subsidiary of Co-Diagnostics, Inc., and they verify that the Quality Management System of DNA Logix fulfills the standards for design, development, testing, and manufacturing of tuberculosis tests and their components.
As mentioned in a previous shareholder update, ISO certification is held in such high esteem that once a product or process is ISO-certified, then being granted a European CE mark is generally considered to be all but assured following a brief assessment and processing period. Any product bearing a CE mark complies with all health and safety requirements that apply to that product. It is essential to be able to sell medical, electronic, and telecommunication devices (among others) throughout Europe, and additionally is accepted worldwide by many countries lacking specific regional health and safety standards of their own.
Our next step will be to apply for a CE mark for our tuberculosis tests, which will allow these tests to be marketed and sold throughout the world in any country where a CE mark is recognized. We will also apply to expand the scope of our ISO certification to include every test and product developed and manufactured by Co-Diagnostics and our subsidiaries, allowing us to achieve our goal of sharing our unique, life-saving technology across the globe.
We have many other exciting developments that we look forward to sharing with you in the months to come, including the expansion of our presence in India, increased fundraising activities with an eye toward an entrance onto a public exchange in the foreseeable future, and domestic technology licensing activities that should present a clear pathway to substantial, recurring revenue.
At the close of 2014, we would also like to take this opportunity to thank you, our valued shareholders, for your continued support and interest in our activities. We look forward to moving forward together as we make 2015 our breakout year.