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Monday, 20 November 2023




LEANFA GETS ISO 13485:2016 CERTIFICATION

You all know that Leanfa is certified AEOF since 2017 and ISO9001:2015 since 2018, as a result of a strong commitment towards quality and reliability that its in our Company DNA since the very first day of our story.
Were very happy and proud to tell you that Leanfa has now obtained the ISO 13485:2016 Certificate, the result of years of experience in designing and manufacturing medical-grade devices for our customers, based on microwaves, radiofrequency and laser technologies. Indeed, its a fundamental milestone, but for us its a new starting point of a new, continuous path characterized by technological innovations, adherence to international standards, organizational evolutions and commitment to careful customer listening. This will always be accompanied by careful risk analysis, based on the ISO 14971 standard, not only aimed at safety and functionality of the products, but also at precise evaluation of each stage of design, production and service processes. All of this its now possible thanks to a unique team of human resources, every day sharing valuable technical skills and endless human touch.
Let us also say that working with medical devices has a special meaning for Leanfa: it is our most effective way of using technology for a better world.
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Alfonso Russo

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LEANFA designs and manufactures state-of-the-art Solid-State OEM Microwave and Radiofrequency Generators and Power Amplifiers, in particular for Industrial, Scientific and Medical application...
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