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Page 1: PDEMUCA26264-20200120153044 · EN ISO 13485:2016 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016) DIN EN ISO

Page 2: PDEMUCA26264-20200120153044 · EN ISO 13485:2016 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016) DIN EN ISO

News on the ISO 13485 revision - 2011 - 2012 (now … ISO 13485...Directives are law while the Standards (ISO 13485, ISO 14971, etc.) are adopted docum ents, therefore both practically

ISO 13485:2003 + ISO 9001:2000 Quality System ...presafe.com/sites/default/files/bl_2_3-019e_v12_0.docx · Web viewDS/EN ISO 13485:2012( = EN ISO 13485:2012 and ISO 13485:2003 + Corr

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ISO 13485:2016 Readiness Review - BSI Group 13485 Medical Devices...ISO 13485:2016 Readiness Review ISO ... used in conjunction with ISO 13485:2016. It is not an exhaustive checklist,

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MEDCONF 2013 Vergleich ISO 13485 / QSR (21 CFR …...ISO 13485 / QSR (21 CFR 820) Zusatzforderungen der FDA Unterschiede QSR / 13485 ©2013 Alexander Thern Einleitung ISO 13485 „Es

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