By TAmiRNA GmbH
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TAmiRNA is awarded ISO 13485:2016 certification of its Quality Management System
Vienna, Austria: MicroRNA diagnostic specialist TAmiRNA has announced that it has now received ISO 13485:2016 certification for its Medical Device and Quality Management System. This follows the company’s successful completion of the audit process in 2022 through the German notified body, MDC.
The ISO certification confirms that TAmiRNA’s quality management system (QMS) meets the currently most rigorous regulatory requirements applicable to the medical device industry. TAmiRNA will now apply this high standard to the development and manufacturing of its microRNA-based diagnostic tests, including hepatomiR®, for which a CE-mark (IVDD) was obtained in 2022.
MiRNA testing milestone
TAmiRNA Co-Founder and CEO Dr. Matthias Hackl commented: “We are very proud of this certification as it demonstrates the full commitment of our team to meet customer and international regulatory expectations for our in-vitro diagnostic tests.”
“ISO 13485:2016 is an internationally recognized quality systems standard tailored to the development and manufacturing of medical devices, including in-vitro diagnostic tests. This certification represents an important milestone for our company and reflects our rigorous and risk-based approach to development and commercialization of innovative microRNA-based tests,” Dr. Hackl noted.
About TAmiRNA GmbH
TAmiRNA specializes in technologies for profiling levels of blood-circulating miRNAs and developing multi-parametric classification algorithms (“signatures”). TAmiRNA uses these technologies to develop minimal-invasive diagnostic tests for drug development, early diagnosis, and prognosis of disease, and as companion diagnostic tests to support treatment decisions. TAmiRNA currently commercialized hepatomiR® under the CE-IVD mark for the diagnosis of liver function in liver cancer patients.
For its work on circulating microRNAs in bone disease, TAmiRNA is receiving funding from the European Union’s Horizon 2020 research and innovation program under the MARIE SKŁODOWSKA-CURIE grant agreement no. 860898. For TAmiRNA´s work on novel drug safety biomarkers, TAmiRNA receives funding from the Innovative Medicines Initiative 2 Joint Undertaking “TransBioLine” under grant agreement No. 821283. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. For its work on senescence-associated biomarkers, TAmiRNA is receiving funding from Eureka-Eurostars grant Ab-SENS. For its work on novel liver function biomarkers, TAmiRNA is receiving funding from the Vienna Business Agency.
More information available at: www.tamirna.com
Click on TAmiRNA ISO 13485:2016 to view certificate.
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Click on Medical Device Certification for information on MDC.