Galway, Ireland, August 11- AOTI announced today that it has been granted full ISO 13485 Quality System and CE Certification by its notified body, NSAI.
“We are delighted to receive these certifications, they demonstrate that AOTI has implemented a quality system that places an emphasis on meeting regulatory as well as customer requirements, risk management and the maintenance of effective processes specific to the safe design, manufacture and distribution of it devices” stated Mike Griffiths President and CEO of AOTI, Ltd.
This certification also allows AOTI to CE mark its products and market the complete product range throughout the European Union as well as many other countries worldwide.
AOTI is founded on a decade of experience in providing innovative solutions to resolve severe and chronic wounds worldwide. Our products reduce healthcare costs and improve the quality of life for patients with these debilitating illnesses. Our patented non-invasive Topical Wound Oxygen (two2) therapy is unsurpassed in fully closings Diabetic, Venous and Pressure ulcers alike. AOTI is a private company based in Galway, Ireland with offices throughout the globe. For more information, see www.aotinc.net.