Sisu Global Receives ISO13485 Certificate 

May 28, 2018  

BALTIMORE, Maryland, 28 May 2019 – Today Sisu Global received ISO 13485 Certification. This certification is proof of Sisu’s Quality Management System compliance to the standard for the Medical Device industry.

About Sisu Global: Sisu Global is a corporation headquartered in Baltimore, Maryland. We envision a world where medical technology enables access to healthcare in every community. Right now, 80% of the world’s medical devices are designed for 10% of the world’s population. Sisu aims to change this statistic by designing and scaling medical devices made specifically for the global market. Sisu is the manufacturer of goods including the HEMAFUSE™ System. The HEMAFUSE™ is a device that can support the donor blood ecosystem by providing an option for clinicians to salvage and recycle a patient’s own blood in cases of internal bleeding. This immediate access to blood can shorten the wait time to perform surgery, increase hospital efficiency and provide access to blood where there may be no other option.

Sisu Global’s work has received numerous features such as CBS 60 Minutes, USA Today, Smithsonian.com and awards from GE Healthcare, USAID, the Gates Foundation, and many others. Sisu has presented at scientific and international conferences across the globe.  For more information, please visit our website, https://sisuglobal.health

About HEMAFUSE™: The HEMAFUSE™ is a handheld, mechanical medical device for intraoperative autotransfusion of blood collected from an internal hemorrhage, meant to replace or augment donor blood in emergency situations.  The HEMAFUSE™ is a device that can support the donor blood ecosystem by providing an option for clinicians to salvage and recycle a patient’s own blood in cases of internal bleeding. This immediate access to blood can shorten the wait time to perform surgery, increase hospital efficiency and provide access to blood where there may be no other option.