ISO 13485 Archives - Tamirna - stability for life

9 01, 2025

TAmiRNA ‘2024 In Review’

2025-01-09T14:05:02+01:00January 9th, 2025|biomarker, Biomarker Discovery, biomarkers, CE-IVD, congress, EVscale, exosomes, extracellular vesicle, hepatomiR kit, Illumina NewSeq2000, ISO 13485, liquid biopsies, Liver disease, microRNA, microRNA services, microRNAs, NGS, PCR testing service, quality, sequencing, small RNA-sequencing, smallRNA, test service|Comments Off on TAmiRNA ‘2024 In Review’

2024: A Year of Growth, Innovation, and Collaboration 2024 has come to a close. We are proud to reflect on the milestones and achievements we’ve reached together with our incredible team, customers, partners, and supporters. Here’s a look back at what we accomplished this year: 👩‍🔬 Team Expansion Welcomed 3 talented new members to our growing team. 🏥 Diagnostic Implementation Successfully rolled out our CE-IVD microRNA liver function test in 5+ clinics, advancing molecular diagnostics. ✅ Service Excellence Completed over 80 RNA service projects, achieving 100% customer satisfaction. 🛠 Bioinformatics Innovation Developed 2 new pipelines: isomiR analysis and tRNA analysis, enhancing our capabilities. 🧬 Expanded Service Offerings Added whole-transcriptome sequencing for mRNA, lncRNA, and circRNA in liquid biopsies to our service portfolio. [...]

TAmiRNA ‘2023 In Review’

2024-01-26T11:44:38+01:00January 26th, 2024|biomarker, biomarkers, exosomes, extracellular vesicle, ISO 13485, Liver disease, microRNA, microRNA services, microRNAs, quality, sequencing, smallRNA|Comments Off on TAmiRNA ‘2023 In Review’

One last look back at 2023 before we turn our attention to our goals for 2024: last year brought us progress in many areas, from the development of new laboratory and data analyses to the implementation of hepatomiR® in routine clinical diagnostics and the establishment of important partnerships. Our thanks go to the entire (growing) TAmiRNA team, and our customers and partners! We look forward to working together and to our joint successes in 2024!

We are proud to announce our ISO 13485:2016 certification

2023-03-10T08:28:14+01:00January 31st, 2023|biomarkers, ISO 13485, microRNA, quality, smallRNA|Comments Off on We are proud to announce our ISO 13485:2016 certification

Today we announce that TAmiRNA has received ISO 13485:2016 certification for its Medical Device and Quality Management System after successfully completing the audit through Germany-based notified body MDC. This ISO certification indicates that TAmiRNAs quality management system meets the most current regulatory requirements applicable to the medical device industry. "We are very proud of this certification as it demonstrates the commitment of our team to meet customer and international regulatory expectations," said Matthias Hackl, Co-Founder and CEO of TAmiRNA. 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 [...]