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 propellerhealth.com/enterprise.
About Propeller
Propeller 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