Quality

Quality – Performance – Safety

We take seriously our responsibility of developing, manufacturing and marketing instruments for the benefit of patients. Hence, we strive to sustain and measurably improve the quality and performance of our products, services and processes.

Our quality management oversees the compliance with national, European and international standards and regulations for medical devices during the entire product realization stage and post-market period. Additionally, Medi-Globe has implemented and established controls for standardized work flows and processes within all departments and their constituents to assure excellent instrument performance and product safety of the highest level.

Based on the market feedback and observations from our sales representatives, we fully recognize the necessity for corrective and preventative measures as a useful tool in optimizing our products and processes.

Medi-Globe routinely performs internal audits at our own production plants as well as at the facilities of our raw material and component suppliers. Working together with our suppliers ensures that the goods we purchase are of the highest quality and meet Medi-Globe’s required specifications.

Certificates, product registrations and import licenses

Medi-Globe, GmbH is certified in accordance with ISO 13485, and all products carry the CE mark. In addition, Medi-Globe, GmbH maintains full compliance with Good Manufacturing Practices, (GMPs) and all requirements of international health systems such as , but not limited to, the US Food & Drug Administration, (FDA), the Canadian Medical Device Regulations, (CMDR) and the Japanese Pharmaceutical Affairs Law, (JPAL).

Please contact our customer service department to request certificates by e-mail at: sales@medi-globe.de


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