Propeller Health Achieves ISO 13485 Medical Device Quality Certification

Thursday, February 8, 2018 Medical Gadgets
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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:

  • 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.

"Having an ISO 13485 quality system means that we have validated processes which enable us to innovate at the speed required to safely bring respiratory health innovation to our patients while rapidly scaling our platform," said Taylor Mahan-Rudolph, Regulatory and Quality Assurance Lead at Propeller Health.

For more technical specs and certifications related to Propeller's platform for managing chronic respiratory disease, please visit

About PropellerPropeller empowers people with asthma and COPD to live measurably better lives. In 2010, Propeller set out to modernize respiratory medicine; enable people to minimize the impact of asthma and COPD on their daily lives; and connect them to their physicians, environment, and community. Propeller's information-powered approach to respiratory management guides physicians and patients to the optimal path of therapy for each individual. With connected inhalers, digital interfaces, and personalized insights, participants receive personal guidance and expert direction anytime. Backed by 3M Ventures (NYSE: MMM), SR One, Hikma Ventures (LON: HIK), Safeguard Scientifics (NYSE: SFE), Social Capital, and other investors, Propeller received the American Telemedicine Association's 2016 President's Award for Innovation in Remote Healthcare and was recognized as one of the top "Fierce 15" medical device companies in 2015 by FierceMedicalDevices. In 2017, Fast Company named Propeller as one of the most innovative companies in health.


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SOURCE Propeller Health

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