NANO4 Global – Announcement of ISO 13485:2017 and ISO 9001:2015 Quality Certification
September 18th - NANO4 Global recently announced that it has passed ISO 13485:2017 and ISO 9001:2015 registrations audits and is now certified to the highest-level of ISO standards. These certifications are a requirement for regulatory purposes. ISO 13485:2017 is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
“At Nano4 Global we focus our efforts on getting the Manufacturing Plant ready for production. These Certifications solidifies our Quality Management System. While nanotechnology is a niche in a growing Diagnostic IVD industry these certifications qualifies NANO4 Global as one of the few IVD nanotechnology producers. This is a key milestone that further recognises our investments in our quality systems, our people and future customers.” stated Alexandra Fernandes, PhD, Co-founder and COO of NANO4 Global.
About NANO4 Global - NANO4 is a start-up launched in 2015 to market innovative nanotechnology based molecular diagnostics and financed by private investors and SME-2 grant from H2020. NANO4 is pioneering a new high-confidence proprietary nanotechnology platform relying on more than 15 years of R&D at Universidade NOVA de Lisboa - Science and Technology, Department of Life Sciences. Nano4 is the next generation of molecular nanodiagnostics applied to life sciences that provides simple readout in under 60 minutes depending on the biomarker.