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media_width_percent=&#8221;100&#8243; uncode_shortcode_id=&#8221;875842&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;9\/12&#8243; uncode_shortcode_id=&#8221;157424&#8243;][vc_custom_heading text_size=&#8221;h5&#8243; uncode_shortcode_id=&#8221;542484&#8243; subheading=&#8221;\u4e34\u5e8a\/\u76d1\u7ba1\u4e13\u5bb6\u3001\u9879\u76ee\u7ecf\u7406\u548c\u751f\u7269\u533b\u5b66\u5de5\u7a0b\u5e08&#8221;]Marco Turturici[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;209127&#8243;]Marco \u5728\u533b\u7597\u5668\u68b0\u884c\u4e1a\u62e5\u6709\u8d85\u8fc7 10 \u5e74\u7684\u7ecf\u9a8c\uff0c\u5728\u4fe1\u606f\u901a\u4fe1\u6280\u672f (ICT) \u548c\u6c7d\u8f66\u884c\u4e1a\u62e5\u6709\u8d85\u8fc7 3 \u5e74\u7684\u7ecf\u9a8c\u3002\u76d1\u7ba1\u4e8b\u52a1\uff1a\u83b7\u5f97\u8ba4\u8bc1\u7684\u76d1\u7ba1\u52a9\u7406\uff0c\u5728\u5236\u5b9a\u6b27\u76df\u548c\u7f8e\u56fd\u5e02\u573a\u51c6\u5165\u7684\u76d1\u7ba1\u8def\u5f84\u65b9\u9762\u7ecf\u9a8c\u4e30\u5bcc\uff1b\u5728\u5ba1\u67e5\u6280\u672f\u6587\u4ef6\u4ee5\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\u4ee5\u53ca\u5411\u76d1\u7ba1\u673a\u6784\u548c\u516c\u544a\u673a\u6784\u63d0\u4ea4\u6280\u672f\u6587\u4ef6\u65b9\u9762\u7ecf\u9a8c\u4e30\u5bcc\u3002\u4f5c\u4e3a MDR\uff08\u7b2c 15 \u6761\uff09\u7684\u8d1f\u8d23\u4eba\uff0c\u4ed6\u7684\u7ecf\u9a8c\u53ef\u4ee5\u9a8c\u8bc1\u6cd5\u89c4\u7684\u8981\u6c42\u3002\u8d28\u91cf\u4fdd\u8bc1\uff1a\u652f\u6301\u7b2c\u4e09\u65b9\u5185\u90e8\u5ba1\u6838\u4ee5\u8fdb\u884c QMS\uff08\u5236\u9020\uff09\uff0c\u5e76\u53c2\u4e0e CE \u6807\u5fd7\u6279\u51c6\u7684\u5916\u90e8\u5ba1\u6838\u3002\u6839\u636e ISO 13485 \u8d1f\u8d23\u533b\u7597\u5668\u68b0\u5f00\u53d1\u7684\u8bbe\u8ba1\u63a7\u5236 (DC)\/\u53d8\u66f4\u6d41\u7a0b\uff0c\u5e76\u6839\u636e ISO 14971 \u8d1f\u8d23\u4ea7\u54c1\u98ce\u9669\u7ba1\u7406 (RM) \u6d41\u7a0b\u3002\u6839\u636e ISO 9001 \u548c MDR 2017\/745 \u5bf9 MDR\uff08\u7b2c 15 \u6761\uff09\u8d1f\u8d23\u4eba\u7684\u89d2\u8272\u8fdb\u884c\u5185\u90e8\u5ba1\u6838\u3002\u6839\u636e\u7cfb\u7edf\u64cd\u4f5c\u7a0b\u5e8f\u5ba1\u67e5\u3001\u64b0\u5199\u548c\u6279\u51c6\u6280\u672f\u6863\u6848\u3002\u5bf9\u8d28\u91cf\u4f53\u7cfb\u7ba1\u7406\u548c\u8bc4\u5ba1\u3001CAPA\u3001FSCA\u3001\u5ba1\u8ba1\u3001\u4f9b\u5e94\u5546\u7ba1\u7406\u6709\u6df1\u5165\u7684\u7406\u89e3\u3002\u4e34\u5e8a\u7ecf\u9a8c\uff1a\u64b0\u5199\u3001\u5408\u89c4\u6027\u5ba1\u67e5\u548c\u53d1\u5e03\u4e34\u5e8a\u8bc4\u4f30\u8ba1\u5212 (CEP) \u548c\u62a5\u544a (CER) \u4ee5\u53ca\u4e0a\u5e02\u540e\u4e34\u5e8a\u8ddf\u8e2a\u6d3b\u52a8 (PMS\u3001PMCF\u3001PSUR\u3001SSCP) (MDR\u3001MEDDEV 2.7.1\u3001MEDDEV 2.12.2\u3001ISO 14155 \u548c MDCG \u6307\u5357)\u3002\u6839\u636e ISO 14155:2020 \u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u6709\u4e34\u5e8a\u8c03\u67e5\u7ecf\u9a8c\uff08\u533b\u5b66\u5199\u4f5c\u3001\u76d1\u6d4b\u3001\u5ba1\u8ba1\u3001\u9009\u5740\u3001\u4e0e\u4e3b\u7ba1\u90e8\u95e8\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u6c9f\u901a\u3001\u4f9b\u5e94\u5546 CRO \u7ba1\u7406\uff09\u3002\u5728\u653b\u8bfb\u5fc3\u8840\u7ba1\u751f\u7406\u5b66\u535a\u58eb\u5b66\u4f4d\u548c\u535a\u58eb\u540e\u6d3b\u52a8\u671f\u95f4\uff0c\u5177\u6709\u5728\u56fd\u9645\u671f\u520a\u4e0a\u53d1\u8868\u533b\u5b66\u6587\u7ae0\u7684\u533b\u5b66\u5199\u4f5c\u7ecf\u9a8c\u3002[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;134148&#8243;][vc_column width=&#8221;3\/12&#8243;][vc_single_image media=&#8221;72&#8243; media_width_percent=&#8221;100&#8243; uncode_shortcode_id=&#8221;936956&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;9\/12&#8243; uncode_shortcode_id=&#8221;157424&#8243;][vc_custom_heading text_size=&#8221;h5&#8243; uncode_shortcode_id=&#8221;126965&#8243; subheading=&#8221;\u9ad8\u7ea7\u9879\u76ee\u7ecf\u7406 &#8211; \u5b89\u5168\u7ecf\u7406&#8221;]Emma Gonz\u00e1lez[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;489652&#8243;]Emma Gonz\u00e1lez \u5973\u58eb\u5728\u4e34\u5e8a\u7814\u7a76\u884c\u4e1a\u62e5\u6709\u8d85\u8fc7 15 \u5e74\u7684\u7ecf\u9a8c\uff0c\u662f MD-Clinicals \u7684\u9ad8\u7ea7\u9879\u76ee\u7ecf\u7406\uff0c\u8d1f\u8d23 CRA \u56e2\u961f\u7684\u89c4\u5212\u548c\u8d44\u6e90\u914d\u7f6e\u3002\u5728\u591a\u4e2a\u9886\u57df\u63d0\u4f9b\u4e30\u5bcc\u7684\u6cbb\u7597\u7ecf\u9a8c\uff0c\u5e76\u6210\u529f\u7ba1\u7406\u9879\u76ee\uff0c\u5305\u62ec\u8d44\u6e90\u89c4\u5212\u3001\u9884\u7b97\u548c\u534f\u8c03\u3002\u5979\u66fe\u5728\u591a\u4e2a\u6cbb\u7597\u9886\u57df\u5de5\u4f5c\uff0c\u5305\u62ec\u80bf\u7624\u5b66\u3001\u5fc3\u8840\u7ba1\u3001\u8840\u6db2\u5b66\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u3001\u5185\u5206\u6ccc\u5b66\u3001\u5fc3\u810f\u75c5\u5b66\u3001\u7259\u5468\u75c5\u5b66\u3001\u98ce\u6e7f\u75c5\u548c\u810a\u9ad3\u635f\u4f24\u3002\u81ea 2019 \u5e74\u4ee5\u6765\uff0c\u5979\u8fd8\u62c5\u4efb MDR \u8303\u56f4\u5185\u7684\u5b89\u5168\u7ecf\u7406\uff0c\u786e\u4fdd\u65f6\u95f4\u8868\u62a5\u544a\u548c\u4e0e\u76d1\u7ba1\u673a\u6784\u7684\u4e3b\u8981\u8054\u7edc\u6c9f\u901a\u6e20\u9053\uff0c\u4e3b\u6301\u5185\u90e8\u56e2\u961f\u6210\u5458\u7684\u57f9\u8bad\u5e76\u4e3a\u5ba2\u6237\u63d0\u4f9b\u5b89\u5168\u4e3b\u9898\u6307\u5bfc\u3002[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;134148&#8243;][vc_column width=&#8221;3\/12&#8243;][vc_single_image media=&#8221;78&#8243; media_width_percent=&#8221;100&#8243; uncode_shortcode_id=&#8221;332177&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;9\/12&#8243; uncode_shortcode_id=&#8221;157424&#8243;][vc_custom_heading text_size=&#8221;h5&#8243; uncode_shortcode_id=&#8221;162258&#8243; subheading=&#8221;\u751f\u7269\u7edf\u8ba1\u5b66\u5bb6 &#8211; \u4e34\u5e8a\u6570\u636e\u7ecf\u7406&#8221;]Yatma Sarr[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;344627&#8243;]\u6211\u662f Yatma Sarr\uff0c\u4e00\u4f4d\u7ecf\u9a8c\u4e30\u5bcc\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u5bb6\uff0c\u62e5\u6709\u8d85\u8fc7 10 \u5e74\u7684\u4e13\u4e1a\u77e5\u8bc6\u3002\u6211\u83b7\u5f97\u4e86\u5df4\u9ece\u7b1b\u5361\u5c14\u5927\u5b66\u751f\u547d\u79d1\u5b66\u5e94\u7528\u6570\u5b66\u548c\u7edf\u8ba1\u5b66\u5b66\u4f4d\uff0c\u6700\u8fd1\u83b7\u5f97\u4e86\u54c8\u4f5b\u5927\u5b66\u751f\u7269\u7edf\u8ba1\u5b66\u65b9\u6cd5\u4e0e\u5e94\u7528\u8bc1\u4e66\u3002\u8fd1\u5e74\u6765\uff0c\u6211\u7684\u4e13\u4e1a\u91cd\u70b9\u96c6\u4e2d\u5728\u533b\u7597\u5668\u68b0\u4e34\u5e8a\u7814\u7a76\u7ec4\u7ec7 (CRO) \u7684\u52a8\u6001\u683c\u5c40\u4e0a\u3002\u5728\u6211\u7684\u6574\u4e2a\u804c\u4e1a\u751f\u6daf\u4e2d\uff0c\u6211\u57f9\u517b\u4e86\u751f\u7269\u7edf\u8ba1\u5b66\u65b9\u9762\u7684\u4e13\u4e1a\u6280\u80fd\uff0c\u7279\u522b\u662f\u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u590d\u6742\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u548c\u5206\u6790\u65b9\u9762\u3002\u6211\u4e3a\u8be5\u4e13\u4e1a\u9886\u57df\u5404\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u7684\u9879\u76ee\u6210\u529f\u505a\u51fa\u4e86\u91cd\u5927\u8d21\u732e\u3002\u9664\u4e86\u6211\u5728\u533b\u7597\u5668\u68b0\u7814\u7a76\u65b9\u9762\u7684\u4e13\u4e1a\u77e5\u8bc6\u5916\uff0c\u6211\u7684\u6280\u80fd\u8fd8\u6269\u5c55\u5230\u66f4\u5e7f\u6cdb\u7684\u9886\u57df\uff0c\u4f8b\u5982\u80bf\u7624\u5b66\u3001\u6570\u636e\u79d1\u5b66\u3001\u7814\u53d1 (R&amp;D)\uff0c\u5305\u62ec DNA \u548c RNA \u6d4b\u5e8f\u7b49\u3002\u6211\u5bf9\u7cbe\u786e\u548c\u5353\u8d8a\u7684\u627f\u8bfa\uff0c\u52a0\u4e0a\u654f\u9510\u7684\u5206\u6790\u601d\u7ef4\uff0c\u4f7f\u6211\u6210\u4e3a\u80fd\u591f\u9a7e\u9a6d\u7edf\u8ba1\u5206\u6790\u590d\u6742\u6027\u7684\u5b9d\u8d35\u8d44\u4ea7\u3002\u6211\u6e34\u671b\u4ee5\u5f00\u653e\u7684\u89c6\u89d2\u548c\u4e13\u4e1a\u7684\u6001\u5ea6\uff0c\u5229\u7528\u6211\u7684\u7ecf\u9a8c\u4e3a\u672a\u6765\u5404\u4e2a\u9886\u57df\u7684\u6210\u529f\u505a\u51fa\u6709\u6548\u8d21\u732e\u3002[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;134148&#8243;][vc_column width=&#8221;3\/12&#8243;][vc_single_image 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