Jan 5 2010
MedApps, Inc., a leading Mobile Wireless Remote Patient Monitoring solution, announced today that it has successfully completed rigorous audits of its Quality Management System (QMS) and received ISO 13485:2003, ISO 9001:2008 and MDD from Underwriters Laboratories (UL), one of the most challenging auditing bodies in the world. ISO 13485:2003 is an International standard for quality systems supporting the design, development and manufacturing of medical devices.
MedApps has subsequently received the CE Mark and CMDCAS allowing its products to be distributed throughout Europe and Canada.
"This is a tremendous accomplishment by the MedApps team," stated Kent Dicks, MedApps' Founder and CEO. "Although it has taken longer than others, I personally take extreme pride in knowing that MedApps has done it right from the very beginning, and is built on a solid regulatory foundation. MedApps has achieved 2 FDA Clearances, FCC Certifications, AT&T and Verizon Certification, and now ISO 13485 / 9001 and CE Mark. This milestone will not only allow MedApps to expand upon its worldwide presence, but will give confidence to clients and patients alike that they are part of a solution that has quality and patient safety as the top priority."