Quality - Performance - Safety
Our quality management (QM) monitors compliance with the relevant national, European and international standards and regulations for the development, manufacture and marketing of our instruments. In addition, our QM department continuously monitors standardized workflows and processes in all departments and production facilities of the company in order to, among other things, ensure the highest possible level of product quality. On the basis of user feedback and market observations of our sales structures, the QM department evaluates the necessary measures to optimize products and processes.
The Medi-Globe Group monitors routine audits of our suppliers to ensure that raw materials and components are always supplied and manufactured according to the agreed specifications.
Certificates, product registrations and import licenses
All our products are not only certified according to ISO 13485:2016, but also carry the CE mark. We operate in accordance with Good Manufacturing Practices, or GMP, and the requirements of international healthcare systems, such as the U.S. Food & Drug Administration (FDA), the Canadian Medical Device Regulations (CMDR), and the Japanese Pharmaceutical Affairs Law (JPAL). In addition, reference is made to all other applicable laws, rules, standards and regulations. We are currently taking the final steps necessary to fully comply with the requirements of the upcoming MDR.