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MDSS

Business Consulting and Services

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MDSS

Overview

Medical Device Safety Service GmbH (MDSS) is a professional “Authorized Representative” (EC REP) located in Germany. Serving the In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers worldwide since 1994. Whatever you like to know about the EU Regulation concerning those products, contact us! The EC REP acts on behalf of the manufacturer as the main contact for the European Commission and the National Competent Authorities. MDSS specializes in the additional registration requirements imposed by member states. Vigilance and Market Surveillance are an integral part of our EC REP service. Contact us in regards to your Free Sales Certificates. This applies for the new European CE marking regulations (MDR and IVDR) and as long as needed for our clients according to the current legislations (MDD, IVDD, AIMDD and its national transpositions). MDSS is certified to EN ISO 13488.

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    Lower Saxony's Ministry of Culture, 5, Hans-Böckler-Allee, Bult, South-City-Bult, Hanover, Region Hannover, Lower Saxony, 30173, Germany

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    Manchester, Greater Manchester, England, United Kingdom

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