Research & Development
Propeller Health receives ISO 13485 medical device quality certification
9 February 2018 -

Respiratory medicine company Propeller Health stated on Thursday that it has passed the International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems,

The ISO certification confirms the company is providing the best quality management systems and regulatory compliance for sensors, apps as well as services.

According to the company, the US 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 clinician tools are used by providers to help improve care and treatment and strengthen relationship with patients.

ISO is an independent, non-governmental international organisation with a membership of 162 national standards bodies based in Geneva, Switzerland. The 13485:2016 is the latest update to the ISO criteria, which was previously revised in 2003.

To achieve certification, the company spent six months undergoing independent review of the processes, documentation and general culture of quality in accordance with ISO guidelines. The ISO certification builds on the US FDA's quality management system principles and is recognised internationally.