We are proud to announce that we have defined our QMS and we can now market our product.
gMendel is proud to announce that we have managed to define a robust quality management system (QMS) and a risk management process, conforming to ISO 13485 and ISO 14971, respectively.
Following 4,5 months of intensive work, together with Star, our strategic partner in meeting regulatory requirements, we have managed to finalise and fully document our QMS, according to international standards. In particular, during these past months, we conducted a complete evaluation process and review as part of a rigorous internal audit, in order to assess the effectiveness and compliance of our quality management system and risk management process against the requirements of ISO 13485 and ISO 14971, respectively. In both cases, zero non-conformity issues were identified, only a few improvement points.
To us, the gMendel team, this is a truly major accomplishment, considering the short timeframe; not only does it demonstrate clearly the robustness and maturity of our work, but also our strong focus on delivering the highest possible quality and safety standards to all patients and users of our product.
After achieving this great milestone, and in compliance with the In Vitro Diagnostic Medical Devices (IVDD) EU Directive, gMendel is now legally entitled to commercially launch the first version of our product, our novel diagnostic tool for the detection of 6 chromosomal aberrations, supported by the Phivea™Platform, a comprehensive decision support dashboard for healthcare professionals.
Next step: external audit for certification
Our next goal is to become ISO 13485 certified. To this end, starting in January 2022, we will go through an external audit, which will be executed by Lloyd’s Register. Our plan is to be able to launch the next versions of our product, complying with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), by the end of 2022.
11 May 2022Denmark's vision to become a front-runner in the use of artificial intelligence reflects on the country's national strategy for AI.
06 May 2022gMendel® announces CE marking for its Phivea® v1.0.0 platform, a novel screening technology for the detection of Klinefelter Syndrome.
26 Apr 2022Recent systematic review determines the prevalence of Klinefelter syndrome amongst transgender individuals presumed male at birth.
18 Apr 2022Level of liver fibrosis in children diagnosed with cystic fibrosis is possible to be assessed with the use of elastography, according to latest study.