MediPines Corporation Achieves ISO 13485 Certification

MediPines Corporation has 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 U.S. Food and Drug Administration 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 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. 
 
In late April, Health Canada, the regulatory agency governing medical devices in Canada, authorized the emergency importation and sale of the MediPines AGM100 to help combat the COVID-19 pandemic in Canada. 
 
According to Dr. Philip Ainslie, professor and Canada Research chair, and co-director for the Centre of Heart, Lung, & Vascular Health at the University of British Columbia, “We have extensively used and validated the MediPines AGM100 in numerous physiological and clinical scenarios. It provides a safe, reproducible and valid measure of non-invasive pulmonary gas exchange.”