[vc_row row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css_animation=”” css=”.vc_custom_1475483357631{padding-top: 70px !important;padding-bottom: 70px !important;}”][vc_column][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=”element_from_fade”][vc_column_inner][vc_column_text]<\/p>\n
[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image=”15648″ background_image_as_pattern=”without_pattern” css_animation=”” css=”.vc_custom_1475740857102{padding-top: 70px !important;padding-bottom: 70px !important;}”][vc_column width=”1\/2″][vc_column_text css=”.vc_custom_1475740885867{padding-bottom: 20px !important;}”]So how do we achieve it? It\u2019s quite simple:<\/span>[\/vc_column_text] <\/div>[\/vc_column][vc_column width=”1\/2″][vc_column_text]Part of this strategy is to ensure total compliance to regulatory guidelines. We achieve this by leveraging our extensive industrial knowledge on various procedures – from product registration and CE marking, maintenance of the Device History Record (DHR) and technical file, biocompatibility testing and validation and support sterilization, to updates on regulations and communication of new\/revised regulations and intellectual property protection.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css_animation=”” css=”.vc_custom_1475740970399{padding-top: 70px !important;padding-bottom: 70px !important;}”][vc_column][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=”” css=”.vc_custom_1475741003970{padding-bottom: 20px !important;}”][vc_column_inner][vc_column_text]<\/p>\n [\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_accordion active_tab=”false” collapsible=”yes” style=”accordion”][vc_accordion_tab title=”Click here to full the view list.”][vc_column_text]All Forefront Medical facilities are certified to latest ISO 13485:2016 version. All facilities are also compliant to MDD 93\/42\/EC which is the Medical Devices Directive for European Community, MHLW Japan\u2019s Pharmaceutical Affairs Law (PAL) and Ministerial Ordinance #169, ISO 15378 which is focused on primary packaging materials for medicinal products.<\/p>\n <\/p>\n All manufacturing facilities are registered under US FDA and Japan as Foreign Medical Device Manufacturer. Our China Jiangsu facilities currently holds a NMPA establishment registration for Class III Product registered (510K), as well as China National Medical Product Administrator (NMPA).<\/p>\n [\/vc_column_text][\/vc_accordion_tab][\/vc_accordion][\/vc_column][\/vc_row][vc_row row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css_animation=””][vc_column][vc_column_text]\n
In addition, all our facilities are accredited to leading medical and quality management systems.\u00a0<\/span><\/h3>\n
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