SOMERVILLE, Mass., August 15, 2019 — Podimetrics, a care management company with the leading solution to help prevent costly and deadly diabetic foot ulcers, announced today it was recently granted ISO 13485:2016 certification for Medical Device and Quality Management Systems from TÜV SÜD, the German notified body. ISO 13485:2016 is an international standard that sets the requirements for a quality management system specific to the medical devices industry.
“We are proud to receive this certification confirming our quality management system is world class,” said David Linders, Podimetrics CTO and co-founder. “This is further validation of our dedication to providing high-quality and safe products for our patients. Along with our FDA 510(k) clearance and American Podiatric Medical Association Seal of Approval, this ISO 13485 certification demonstrates the high standards to which Podimetrics operates. We are committed to fulfilling the strictest regulatory requirements to earn our customers’ trust.”
The new ISO 13485:2016 certification demonstrates that the design, development, production, sales, and distribution of Podimetrics’ remote patient monitoring system are performed to the highest quality and regulatory standards.
Podimetrics is currently being used by patients across the United States. The company helps physicians detect and prevent costly and deadly diabetic foot ulcers by having patients simply place their feet on the cellular connected SmartMat for just 20 seconds a day. The data is then seamlessly and automatically sent to the Podimetrics care team, who triage any concerning findings to help patients receive appropriate, preventive treatments under the direction of their clinician. While diabetic foot ulcers are but one complication of diabetes, they have a devastating effect on patients’ lives, often progressing to debilitating wounds and amputations, and they are a significant driver of health care costs — a single amputation costs up to $100,000.
Podimetrics is a care management company with the leading solution to help prevent diabetic foot ulcers (DFU), one of the most debilitating and costly complications of diabetes. On behalf of payers and at-risk providers, we send high-risk patients our FDA-cleared, cellular-connected SmartMat. After placing their feet on the mat for just 20 seconds a day, patients’ data are automatically sent to our care management team that triages any concerning findings. By combining cutting-edge technology with best-in class care management, Podimetrics earns high engagement rates from patients and allows clinicians to achieve unparalleled outcomes saving limbs, lives, and money. Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics is headquartered in Somerville, MA an backed by Norwich Ventures, Scientific Health Development, and Rock Health. For more information, go to www.podimetrics.com or follow us on Twitter @podimetrics.