- ISO certification affirms to Propeller's patients and partners that the company is providing the best quality management systems and regulatory compliance for sensors, apps, and services.
- To achieve certification, Propeller spent six months undergoing independent review of the company's processes, documentation, and general culture of quality in accordance with ISO guidelines.
- The ISO certification builds on the FDA's quality management system principles and is recognized internationally.
- Propeller's Agile-Kanban software development process was also part of the certification — critical in proving the company meets the stringent requirements of ISO 13485 while continually improving its software and digital experiences.
- ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies based in Geneva, Switzerland.
- 13485:2016 is the latest update to the ISO criteria, previously revised in 2003. This long-awaited revision expands risk management, adds new safeguards, and outlines new policies for quality control in supply chain management.
- Propeller also just announced HITRUST CSF Certification for the security of protected health information.
MADISON, Wis., Feb. 8, 2018 /PRNewswire/ -- Propeller Health, the leading digital solution for respiratory medicine, has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems. Propeller's FDA-cleared medical devices include sensors that attach to inhalers and mobile apps powered by a robust analytics platform helping patients better manage their asthma and COPD symptoms. The platform's clinician tools are used by providers and healthcare organizations to help improve care and treatment and strengthen their relationship with patients. This ISO certification is another milestone for Propeller following the company's recently announced partnership with the largest pharmacy benefit management organization in the U.S., Express Scripts, and expansion of work with GlaxoSmithKline. About Propeller's ISO 13485 certification: