Consulting Consulting for Quality-Management-Systems according to EN ISO 9001:2000 and EN ISO 13485:2003 directives  Consulting for Annexes II,   V, VI according to the   directives of MDD  93/42/EEC  Conception of Main product  files of Medical Products for  approval of CE-Mark with  notified body number f.e.  CE-0297  EMC-Approvals for  documentation of patient  safety according to EN ISO  and MDD directives  Consulting for FDA approval  f.e. directives 510 K  Management of clinical  assesments and clinical  approvals according to the  MDD 93/42/EWG directives  and EN ISO 14971  riskmanagement Management of Field studies Translation and conception of Instructions for use for medical products Organization and Operation of seminars and workshops concerning different medical topics