Preventice, a developer of mobile health applications and remote monitoring systems, has received ISO 13485: 2003 certification for its quality management system.
As per the ISO requirements of the quality management system, an organization should show its ability to serve medical devices and related services that consistently meet the customer requirements.
Preventice co-founder, president and CEO Jon Otterstatter noted ISO 13485: 2003 certification is a globally recognized standard that signals to the company’s customers, strategic partners and the broader industry that Preventice abides by the highest standards for quality and manufacturing.
"There is a rapidly growing appetite for remote monitoring technology as a solution to current and future health care needs, and the ISO certification demonstrates our adherence to industry standards and sets the stage for us to expand our reach, providing a clinically sound solution in the BodyGuardian RMS," Otterstatter added.
The company believes that this ISO certification will support in securing CE Mark approval for its BodyGuardian remote monitoring system (BodyGuardian RMS).