VIVE - MedTech GmbH

Generating summary...

VIVE-MedTech GmbH is a German medical device manufacturer focused on the development, production, and distribution of medical devices, devices for clinical research, and quality management systems, along with consulting and prototyping services. The company provides eQMS and Product Lifecycle Management solutions and offers Quality Affairs and Regulatory Affairs guidance to small, medium, and large organizations to support regulatory compliance and efficient processes. Founded on 20 September 2019, VIVE-MedTech develops and markets devices for COPD and COVID-19 pneumonias, including patient-specific oxygenators, optimized ECMO blood pumps, blood gas monitoring and regulation systems, and specialized catheters for extracorporeal circulation, for use by clinicians internationally. The organization operates with a main site in Cottbus, Brandenburg, and a secondary location in the Ruhr region, and maintains a quality management system certified to EN ISO 13485:2021 with compliance to EU MDR, 21 CFR Part 820, and MDSAP, as certified by Berlin Cert. The company emphasizes regulatory compliance and process optimization to meet international medical device requirements.