EUにおける医療機器のヴィジランス報告 法的根拠 Salma
Contents
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3. 00 00 00000000 00000000 000001 non na nin atom mmmmmmmmmmmmmmmmmmnmmmmr nn ann ndin man nn non nn nin in 5 MDD 93 42 7 90 385 EEC 5 98 79 EC PMSI 1 1 non DL D DL DICE DTO CIL OE CI DI I AIMDD x MDD 93 42 EEC IVDD 98 79 EC 90 385 008 10
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6. nnnnmmpmnmnmmmmnmnmmmpmnmnmm nmm mmn mmm np pn nun nn non nn ona mmm pn nmmgmmmn Bm Bri pn BBELE E 5 nmn 1 MEDDEV 212 4 1 50 102007 4 2 4 200801 DET ET EL EL FE EL EL 1 15 TEL EL EL EL EL TU ET N N 93 42 1993 6r 141 amp 90 385 EEC 1990 6 2011 5 98 79 1998 101 27 6 7 1H 2l 8 004 9 10 111 5l 11 0 04 12 0 0 2 1 ISO 13485 72003 1 14 000000007150 SO 14971020070 000 E d dd gd d D DO BD DT T nnl 15
7. Salma Michor PhD RAC 1 1 0 5 mm mmn Imm mn I Bran T nnnnnnnnnnnnr nona PMsm n nmm n md m md mg agni non nm mmm nm mmm mm Wm m I pnm n pn mmm nmm pm prm n pr HE I n mnnmmn mmn mmm pi
8. nnmmmnnmnmmmmnnmmnmmnnmnmnnmnmmm mmm m mmm mni 5 ON nan 93 42 1993 er 140 rr 10m0 00 0000 90 385 1990 er 200 4 mn smn n gum nr 98 79 1998 100 270 5 m TN rm 2007 47020070 90 50 m 93 42 90 385 O O 98 8 ECTT nir i EL ELEL EL EL BEBE FE EL EL EL EL EE EL EL EI BL BL EI BEL FT LIBE EL EL EL FT I nnmnmnmnmnnnm m nmmml
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12. 00 1 16 0011 17 00 1 18 111 1l 19 00 1 00 Salma Michor PhD RACT Michor Consulting eug CEOD 0 0 000 0 00000 00 00000 ooo 00 000 0000 0 0 IWyeth richiesip 00 00000000000000 0 00 0 000 00 Regulatory Focus 00 0 00 000 0000000 0 Umichor_salmaQ hotmail com Copyright 2009 by the Regulatory Affairs Professionals Society RAPS Reprinted from the September 2009 issue of Regulatory Focus with the permission of RAPS
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