ISO 13485 is the harmonized standard for Quality management system (QMS) in the medical device industry.
Upfront diagnostics announced today that their LVOne has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification follows the design, development, manufacturing, and distribution of a rapid blood test for the diagnosis of stroke patients, highlighting the company’s adherence to rigorous quality standards.
ISO13485 focuses on patient safety by ensuring the consistent quality throughout the entire lifecycle of medical devices, from design and production to disposal. It outlines the requirements needed for organizations to establish a QMS that demonstrates their capability to consistently and safely deliver medical devices, and related services, to meet customer and regulatory requirements. The standard covers all aspects of a product’s lifecycle, from initial design and development through production and distribution, to promote product safety and reliability. ISO 13485 certification also facilitates access to international markets by aligning with various regulatory requirements as CE mark and FDA.
Dr Edoardo Gaude, Chief Scientific Officer, Upfront diagnostics, says;
“ISO 13845:2016 certification shows Upfront diagnostics focus in quality and further confirms to customers our commitment to continuous improvement, along with the safety and effectiveness of our technology.”
Gonzalo Ladreda, Chief Executive Officer, says
“This achievement puts the LVOne one step closer to the stroke patients, it also confirms the readiness of our technology and the excellent work that our scientific team delivers.”
Story by Upfront Diagnostics
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