gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives
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Home News gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives
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gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives

MARCH 21, 2022 Members' News
BHH member gMendel, a Danish biotech company aiming to transform the diagnosis of genetic disorders for better disease management, is now certified with ISO 13485, within the scope “Design and Development and Service Provision of In Vitro Diagnostic Medical device software”. Following this great milestone, gMendel is now legally entitled to commercially launch version 1.0.0 of Phivea®Platform, the novel screening tool for the detection of Klinefelter syndrome. The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.  The ISO 13485:2016 certification demonstrates gMendel’s commitment to providing high-quality and consistent products and services to its clients. Currently, the company is preparing for the 2017/746 IVDR. Barcelona Health Club and gMendel partnered in 2021 under the common vision to accelerate digital transformation in healthcare and advance the efficient uptake of new healthcare technologies in the European regulatory and legislative framework.   Read the full article here. 
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