{"id":10,"date":"2020-08-06T16:37:38","date_gmt":"2020-08-06T16:37:38","guid":{"rendered":"https:\/\/www.cretexmedical.com\/cdt\/regulatory-quality\/"},"modified":"2025-09-15T16:24:28","modified_gmt":"2025-09-15T16:24:28","slug":"regulatory-quality","status":"publish","type":"page","link":"https:\/\/www.cretexmedical.com\/cdt\/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;215&#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<\/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<p class=\"x_MsoNormal\">At the beginning of every new project, we work together with our customers to assure that quality is built into the products in the design stages. We accomplish this through our Stage Gate process with deliverables that include:<\/p>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Advanced Product Quality Planning (APQP)<\/li>\n<li class=\"x_MsoNormal\">Failure Mode and Effects Analysis (FMEA)<\/li>\n<li class=\"x_MsoNormal\">Statistical Based Control Planning (CP)<\/li>\n<li class=\"x_MsoNormal\">Measurements System Analysis (MSA)<\/li>\n<li class=\"x_MsoNormal\">Installation Qualification (IQ)<\/li>\n<li class=\"x_MsoNormal\">Operational Qualification (OQ)<\/li>\n<li class=\"x_MsoNormal\">Production Qualification (PQ)<\/li>\n<\/ul>\n<p class=\"x_MsoNormal\">We ensure that our processes have the documentation and traceability to meet the current medical device industry standards and practices.<\/p>\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&#8221; use_theme_fonts=&#8221;yes&#8221; el_id=&#8221;metrology&#8221;][vc_column_text]We continually invest in precision technology and employ a variety of software such as PC-DMIS, InSpec, MeasureMind 3D, Zone 3, Calypso and others to ensure we are meeting your highest quality standards.<\/p>\n<ul>\n<li class=\"x_MsoNormal\">\u00a0CMM\n<ul>\n<li>Zeiss Prismo Ultra<\/li>\n<li>Hexagon Advantage<\/li>\n<\/ul>\n<\/li>\n<li>Vision Systems\n<ul>\n<li>SmartScope<sup>TM<\/sup> (OGP Quest &amp; Flash)<\/li>\n<li>Visicon Sierra<\/li>\n<li>Visicon FS-85<\/li>\n<li>MicroVu<\/li>\n<li>Keyence IM<\/li>\n<\/ul>\n<\/li>\n<li>3D Surface Profiling with Keyence VM<\/li>\n<li>Digital Video Linear Measurement Systems (DVLMS)<\/li>\n<li>Laser Micrometers (Mitutoyo\/Keyence)<\/li>\n<li>Tensile and Elongation Testers (Lloyd instruments &amp; Mark-10)<\/li>\n<li>XRF Testing of Incoming Raw Materials<\/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\">The Cretex Medical Group of companies is 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 class=\"x_MsoNormal\">Brooklyn Park, Minnesota<\/h4>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\"><a href=\"https:\/\/www.cretexmedical.com\/cdt\/wp-content\/uploads\/sites\/4\/2025\/02\/CTXBP_SX_2468805-1_Main_EN_extsigned-Certificate.pdf\" target=\"_blank\" rel=\"noopener\">EN ISO 13485:2016<\/a> (Component and Device Technologies, Inc. \/ JunoPacific, Inc.)<\/li>\n<li class=\"x_MsoNormal\"><a href=\"https:\/\/www.cretexmedical.com\/cdt\/wp-content\/uploads\/sites\/4\/2025\/07\/MEIER_SX_2444948-1_Main_EN_extsigned.pdf\" target=\"_blank\" rel=\"noopener\">EN ISO 13485:2016<\/a> (Meier Tool &amp; Engineering, Inc.)<\/li>\n<li>FDA Registration as a Contract Manufacturer<\/li>\n<\/ul>\n<h4 class=\"x_MsoNormal\">Dassel, Minnesota<\/h4>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\"><a href=\"https:\/\/www.cretexmedical.com\/cdt\/wp-content\/uploads\/sites\/4\/2025\/09\/SPECT_SX_2233460-1_Annex_EN_2025_extsigned.pdf\" target=\"_blank\" rel=\"noopener\">EN ISO 13485:2016<\/a> (Spectralytics, Inc.)<\/li>\n<\/ul>\n[\/vc_column_text][\/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; bottom_padding=&#8221;4%&#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; advanced_gradient_angle=&#8221;0&#8243; overlay_strength=&#8221;0.3&#8243; 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