Wireless remote monitoring company MedApps announced that it has received ISO 13485:2003 and ISO 9001:2008 certification from Underwriters Laboratories (UL), which subsequently led to a CE Mark certification and CMDCAS approval, enabling the company to market its products throughout Europe and Canada.
To date, MedApps has secured two FDA clearances, various FCC certifications, AT&T and Verizon certifications in addition to the recent ISO 13485 / 9001 and CE Mark certification, according to the company's CEO and Founder Kent Dicks.
MedApps' core product offering today is HealthPAL, a device that is about the size of a cell-phone but with fewer buttons. The company explains that the buttons are for special features and set-up, and that the reading and data transmissions are automated. In other words: “The patient does not push any buttons, navigate any screen commands or touch the HealthPAL in any fashion.” HealthPAL can synch to off-the-shelf personal medical devices like blood glucose meters for wireless, remote chronic disease management. MedApps has plans to launch a whole suite of form factors for devices or applications in the coming year.
"Although the stringent process has taken significant resources in time and energy, the investment has put us ahead of others in the telehealth space. I personally take extreme pride in knowing that all of us at MedApps have put our best foot forward to do it right from the very beginning, and we’ve built our system on a solid regulatory foundation," Dicks stated in a company press release.
For more, read the entire press release