MediPines Obtains International MDSAP ISO 13485 Medical Device Certification

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ORANGE COUNTY, Calif., April 9, 2020 /PRNewswire/ — MediPines Corporation announces that it received the Medical Device Single Audit Program certification, MDSAP ISO 13485:2016 certification for Medical Device and Quality Management Systems. MediPines Corporation is the manufacturer of portable respiratory monitoring devices designed to provide real-time, clinically actionable data.  

ISO 13485:2016 is an internationally recognized quality standard developed to ensure the consistent design, development, production, installation and sale of medical devices. To be certified, organizations must pass a rigorous audit that demonstrates the company’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

The Medical Device Single Audit Program (MDSAP) was developed as a global initiative to allow third-party auditors to conduct a single audit of a medical device manufacturer that covers ISO 13485:2016 and their respective regulatory requirements. There are currently five countries participating in MDSAP: USA, Canada, Australia, Japan, and Brazil.

Building on top of implementing Good Manufacturing Practices (cGMP), as defined by the US FDA requirements for registered manufacturers, and rigorous requirements set by the California Department of Public Health for medical device manufacturing licenses in 2019, MediPines continues to expand its scope to include global quality standards to provide the highest quality medical devices to the healthcare community.

“Our MDSAP and ISO 13485 certification demonstrates MediPines’ company-wide commitment to the rigorous organizational standards and recognition of our state-of-the-art medical device manufacturing operation.  MediPines is committed to patient safety and product reliability,” stated Steve Lee, CEO of MediPines.

The MediPines AGM100® 

The MediPines Gas Exchange Monitor, AGM100® , is a portable device used to rapidly assess a patient’s respiratory status, non-invasively.  It is the first technology of its kind to integrate a comprehensive set of critical parameters and innovative respiratory measurements analyzed from a patient’s normal breathing sample in a simple, easy-to-administer breathing test, within a few minutes. 

AGM100 is currently being used to triage and assess COVID-19 patients.   

About MediPines

MediPines Corporation is the manufacturer of portable respiratory devices designed to provide real-time, clinically actionable data.  MediPines’ mission is to advance respiratory medicine by providing physiology-based, non-invasive respiratory devices that empower healthcare providers to advance the quality and operating efficiency of medical care.