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 to development and commercialization of innovative microRNA-based tests.