{"id":10,"date":"2020-08-06T16:37:38","date_gmt":"2020-08-06T16:37:38","guid":{"rendered":"https:\/\/www.cretexmedical.com\/rms\/regulatory-quality\/"},"modified":"2026-03-18T15:46:44","modified_gmt":"2026-03-18T15:46:44","slug":"regulatory-quality","status":"publish","type":"page","link":"https:\/\/www.cretexmedical.com\/rms\/regulatory-quality\/","title":{"rendered":"Regulatory &#038; Quality"},"content":{"rendered":"[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;bottom&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; bg_color=&#8221;#ffffff&#8221; bg_image=&#8221;414&#8243; bg_position=&#8221;center center&#8221; background_image_loading=&#8221;default&#8221; bg_repeat=&#8221;no-repeat&#8221; scene_position=&#8221;center&#8221; top_padding=&#8221;10%&#8221; constrain_group_1=&#8221;yes&#8221; 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overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/6&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][\/vc_column][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; centered_text=&#8221;true&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/3&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_column_text]\n<h2><b>Quality Impacts Lives<\/b><\/h2>\n[\/vc_column_text][vc_column_text]We are committed to meeting and exceeding our customers\u2019 expectations and regulatory requirements throughout our organization. Our Quality Management System (QMS) has been developed to conform to the exacting standards of today\u2019s medical device industry. Our robust QMS is backed by a team of dedicated and highly trained quality professionals, who will assure conformity\u00a0to every specification by employing our advanced metrology systems and measurement techniques to provide you with the highest-quality products and services in the medical device industry.[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/6&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][\/vc_column][\/vc_row][vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; top_padding=&#8221;6%&#8221; constrain_group_1=&#8221;yes&#8221; bottom_padding=&#8221;6%&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; shape_type=&#8221;&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; el_class=&#8221;cdt-sidenav&#8221; advanced_gradient_angle=&#8221;0&#8243; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/4&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; gradient_type=&#8221;default&#8221;][vc_column_text el_class=&#8221;sticky-box&#8221;]\n<ul>\n<li><a href=\"#quality-engineering\">Quality Engineering<\/a><\/li>\n<li><a href=\"#metrology\">Advanced Metrology &amp; Software<\/a><\/li>\n<li><a href=\"#quality-policy\">Quality Policy<\/a><\/li>\n<li><a href=\"#certifications\">Facility Certifications<\/a><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/4&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_custom_heading text=&#8221;Quality Engineering&#8221; use_theme_fonts=&#8221;yes&#8221; el_id=&#8221;quality-engineering&#8221;][vc_column_text]\n<ul>\n<li>Certified and registered QMS<\/li>\n<li>Advanced Product Quality Planning (APQP)<\/li>\n<li>Process Validations\n<ul>\n<li>Installation Qualification (IQ)<\/li>\n<li>Operational Qualification (OQ)<\/li>\n<li>Performance Qualification (PQ)<\/li>\n<li>Special processes<\/li>\n<\/ul>\n<\/li>\n<li>Production Part Approval Process (PPAP)<\/li>\n<li>Process Failure, Modes and Effects Analysis (PFMEA)<\/li>\n<li>Gauge Repeatability and Reproducibility (GR&amp;R)<\/li>\n<li>Capability analysis<\/li>\n<li>Statistical support for validation planning and execution<\/li>\n<\/ul>\n[\/vc_column_text][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;100&#8243;][vc_custom_heading text=&#8221;Advanced Metrology and Software&#8221; use_theme_fonts=&#8221;yes&#8221; el_id=&#8221;metrology&#8221;][vc_column_text]\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Coordinate Measurement Machines (CMMs)<\/li>\n<li class=\"x_MsoNormal\">Vision systems\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Keyence instant measurement system<\/li>\n<li class=\"x_MsoNormal\">Micro-Vu<\/li>\n<\/ul>\n<\/li>\n<li class=\"x_MsoNormal\">3D Scanning\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">CT scanner<\/li>\n<li class=\"x_MsoNormal\">Zygo scanner<\/li>\n<li class=\"x_MsoNormal\">Alicona scanner<\/li>\n<\/ul>\n<\/li>\n<li class=\"x_MsoNormal\">Precision contour measuring equipment<\/li>\n<li class=\"x_MsoNormal\">Profilometers<\/li>\n<li class=\"x_MsoNormal\">SEM analyzer<\/li>\n<li class=\"x_MsoNormal\">Industry-leading statistical software<\/li>\n<\/ul>\n[\/vc_column_text][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;100&#8243;][vc_custom_heading text=&#8221;Quality Policy&#8221; use_theme_fonts=&#8221;yes&#8221; el_id=&#8221;quality-policy&#8221;][vc_column_text]\n<p class=\"x_MsoNormal\">We are committed to:<\/p>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Achieving or exceeding customer expectations<\/li>\n<li class=\"x_MsoNormal\">Ensuring the effectiveness of the quality management system while complying with regulatory requirements<\/li>\n<li class=\"x_MsoNormal\">Empowering and developing employees<\/li>\n<li class=\"x_MsoNormal\">Fostering a culture of operational excellence and continual improvement<\/li>\n<\/ul>\n[\/vc_column_text][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;100&#8243;][vc_custom_heading text=&#8221;Facility Certifications&#8221; use_theme_fonts=&#8221;yes&#8221; el_id=&#8221;certifications&#8221;][vc_column_text]\n<h4>Coon Rapids, Minnesota<\/h4>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\"><a href=\"https:\/\/www.cretexmedical.com\/rms\/wp-content\/uploads\/sites\/6\/2026\/03\/SX_1346728-1_Annex_EN_extsigned.pdf\" target=\"_blank\" rel=\"noopener\">EN ISO 13485:2016<\/a><\/li>\n<li><a href=\"https:\/\/www.cretexmedical.com\/rms\/rmscompanycertscope18mar2028\/\" target=\"_blank\" rel=\"noopener\">ISO\/IEC 17025:2017<\/a><\/li>\n<li>FDA Registration as a Contract Manufacturer: 2183946<\/li>\n<\/ul>\n<h4>Anoka, Minnesota<\/h4>\n<ul type=\"disc\">\n<li><a href=\"https:\/\/www.cretexmedical.com\/rms\/wp-content\/uploads\/sites\/6\/2026\/03\/SX_1346728-1_Annex_EN_extsigned.pdf\" target=\"_blank\" rel=\"noopener\">EN ISO 13485:2016<\/a><\/li>\n<li>FDA Registration as a Contract Manufacturer: 3010009693<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=&#8221;in_container&#8221; 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Quality - RMS<\/title>\n<meta name=\"description\" content=\"Cretex Medical | rms maintains robust regulatory and quality systems to support medical device manufacturing. 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