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CONSULTING



  • Consulting for Quality-Management-Systems according to EN ISO 9001 and/or EN ISO 13485 directives

  • Consulting for Annexes II, V, according to the directives of MDD 93/42/EEC and for receipt of CE-Mark with Notified Body number f.e. CE-0120 SGS

  • Conception of Main Product Files of Medical Products for approval of CE-Mark with Notified Body number f.e. CE-0120 SGS

  • EMC-Approvals for documentation of patient safety according to EN ISO and MDD directives (EN ISO 60601)

  • Management of clinical approvals and clinical assessments according to the MDD 93/42/EEC directives and EN ISO 14971 risk Management

  • Management of Field Studies

  • Conception of official expertises for medical products

  • Consulting - Marketing - Logistics - Distribution
         
         
     
     
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