{"id":237,"date":"2023-02-05T16:03:34","date_gmt":"2023-02-05T21:03:34","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/?page_id=237"},"modified":"2023-04-08T14:50:03","modified_gmt":"2023-04-08T19:50:03","slug":"design-control-2","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/design-control-2\/","title":{"rendered":"Design Control"},"content":{"rendered":"\n<div class=\"wp-block-cover alignfull is-light has-parallax\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim-70 has-background-dim\" style=\"background-color:#f9d0da\"><\/span><div role=\"img\" class=\"wp-block-cover__image-background wp-image-296 has-parallax\" style=\"background-position:50% 50%;background-image:url(http:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-08-at-4.14.20-PM.png)\"><\/div><div class=\"wp-block-cover__inner-container is-layout-flow wp-block-cover-is-layout-flow\">\n<div class=\"wp-block-group alignfull is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-cover alignfull\" style=\"min-height:250px;aspect-ratio:unset;\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-black-background-color has-background-dim-10 has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-flow wp-block-cover-is-layout-flow\">\n<div class=\"wp-block-columns is-not-stacked-on-mobile is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group is-layout-flex wp-block-group-is-layout-flex\">\n\n<h1 class=\"wp-block-site-title has-large-font-size\"><a href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\" target=\"_self\" rel=\"home\">RELIEF TECH TEAM<\/a><\/h1><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><nav class=\"has-text-color has-foreground-color has-large-font-size is-responsive items-justified-right wp-block-navigation is-content-justification-right is-layout-flex wp-container-core-navigation-is-layout-1 wp-block-navigation-is-layout-flex\" aria-label=\"Navigation 4\" \n\t\t data-wp-interactive=\"core\/navigation\" data-wp-context='{\"overlayOpenedBy\":{\"click\":false,\"hover\":false,\"focus\":false},\"type\":\"overlay\",\"roleAttribute\":\"\",\"ariaLabel\":\"Menu\"}'><button aria-haspopup=\"dialog\" aria-label=\"Open menu\" class=\"wp-block-navigation__responsive-container-open \" \n\t\t\t\tdata-wp-on-async--click=\"actions.openMenuOnClick\"\n\t\t\t\tdata-wp-on--keydown=\"actions.handleMenuKeydown\"\n\t\t\t><svg width=\"24\" height=\"24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" focusable=\"false\"><rect x=\"4\" y=\"7.5\" width=\"16\" height=\"1.5\" \/><rect x=\"4\" y=\"15\" width=\"16\" height=\"1.5\" \/><\/svg><\/button>\n\t\t\t\t<div class=\"wp-block-navigation__responsive-container  has-text-color has-black-color\"  id=\"modal-1\" \n\t\t\t\tdata-wp-class--has-modal-open=\"state.isMenuOpen\"\n\t\t\t\tdata-wp-class--is-menu-open=\"state.isMenuOpen\"\n\t\t\t\tdata-wp-watch=\"callbacks.initMenu\"\n\t\t\t\tdata-wp-on--keydown=\"actions.handleMenuKeydown\"\n\t\t\t\tdata-wp-on-async--focusout=\"actions.handleMenuFocusout\"\n\t\t\t\ttabindex=\"-1\"\n\t\t\t>\n\t\t\t\t\t<div class=\"wp-block-navigation__responsive-close\" tabindex=\"-1\">\n\t\t\t\t\t\t<div class=\"wp-block-navigation__responsive-dialog\" \n\t\t\t\tdata-wp-bind--aria-modal=\"state.ariaModal\"\n\t\t\t\tdata-wp-bind--aria-label=\"state.ariaLabel\"\n\t\t\t\tdata-wp-bind--role=\"state.roleAttribute\"\n\t\t\t>\n\t\t\t\t\t\t\t<button aria-label=\"Close menu\" class=\"wp-block-navigation__responsive-container-close\" \n\t\t\t\tdata-wp-on-async--click=\"actions.closeMenuOnClick\"\n\t\t\t><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 24 24\" width=\"24\" height=\"24\" aria-hidden=\"true\" focusable=\"false\"><path d=\"m13.06 12 6.47-6.47-1.06-1.06L12 10.94 5.53 4.47 4.47 5.53 10.94 12l-6.47 6.47 1.06 1.06L12 13.06l6.47 6.47 1.06-1.06L13.06 12Z\"><\/path><\/svg><\/button>\n\t\t\t\t\t\t\t<div class=\"wp-block-navigation__responsive-container-content\" \n\t\t\t\tdata-wp-watch=\"callbacks.focusFirstElement\"\n\t\t\t id=\"modal-1-content\">\n\t\t\t\t\t\t\t\t<ul class=\"wp-block-navigation__container has-text-color has-foreground-color has-large-font-size is-responsive items-justified-right wp-block-navigation has-large-font-size\"><li data-wp-context=\"{ &quot;submenuOpenedBy&quot;: { &quot;click&quot;: false, &quot;hover&quot;: false, &quot;focus&quot;: false }, &quot;type&quot;: &quot;submenu&quot; }\" data-wp-interactive=\"core\/navigation\" data-wp-on--focusout=\"actions.handleMenuFocusout\" data-wp-on--keydown=\"actions.handleMenuKeydown\" data-wp-on-async--mouseenter=\"actions.openMenuOnHover\" data-wp-on-async--mouseleave=\"actions.closeMenuOnHover\" data-wp-watch=\"callbacks.initMenu\" tabindex=\"-1\" class=\"has-large-font-size wp-block-navigation-item has-child open-on-hover-click wp-block-navigation-submenu\"><a class=\"wp-block-navigation-item__content\" href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/\">P.H.A.M.<\/a><button data-wp-bind--aria-expanded=\"state.isMenuOpen\" data-wp-on-async--click=\"actions.toggleMenuOnClick\" aria-label=\"P.H.A.M. submenu\" class=\"wp-block-navigation__submenu-icon wp-block-navigation-submenu__toggle\" ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" viewBox=\"0 0 12 12\" fill=\"none\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M1.50002 4L6.00002 8L10.5 4\" stroke-width=\"1.5\"><\/path><\/svg><\/button><ul data-wp-on-async--focus=\"actions.openMenuOnFocus\" class=\"wp-block-navigation__submenu-container has-text-color has-black-color wp-block-navigation-submenu\"><li class=\"has-large-font-size wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/relief-tech-team-members\/\"><span class=\"wp-block-navigation-item__label\">The FAM<\/span><\/a><\/li><li class=\"has-large-font-size wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/pressure-healing-assistive-mat-p-h-a-m\/the-need-for-pressure-ulcer-relief\/\"><span class=\"wp-block-navigation-item__label\">The PHAM Need<\/span><\/a><\/li><\/ul><\/li><li data-wp-context=\"{ &quot;submenuOpenedBy&quot;: { &quot;click&quot;: false, &quot;hover&quot;: false, &quot;focus&quot;: false }, &quot;type&quot;: &quot;submenu&quot; }\" data-wp-interactive=\"core\/navigation\" data-wp-on--focusout=\"actions.handleMenuFocusout\" data-wp-on--keydown=\"actions.handleMenuKeydown\" data-wp-on-async--mouseenter=\"actions.openMenuOnHover\" data-wp-on-async--mouseleave=\"actions.closeMenuOnHover\" data-wp-watch=\"callbacks.initMenu\" tabindex=\"-1\" class=\"has-large-font-size wp-block-navigation-item has-child open-on-hover-click wp-block-navigation-submenu\"><a class=\"wp-block-navigation-item__content\" href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/design-control-2\/\">Design Control<\/a><button data-wp-bind--aria-expanded=\"state.isMenuOpen\" data-wp-on-async--click=\"actions.toggleMenuOnClick\" aria-label=\"Design Control submenu\" class=\"wp-block-navigation__submenu-icon wp-block-navigation-submenu__toggle\" ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" viewBox=\"0 0 12 12\" fill=\"none\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M1.50002 4L6.00002 8L10.5 4\" stroke-width=\"1.5\"><\/path><\/svg><\/button><ul data-wp-on-async--focus=\"actions.openMenuOnFocus\" class=\"wp-block-navigation__submenu-container has-text-color has-black-color wp-block-navigation-submenu\"><li class=\"has-large-font-size wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/device-requirements\/\"><span class=\"wp-block-navigation-item__label\">Device Requirements<\/span><\/a><\/li><li data-wp-context=\"{ &quot;submenuOpenedBy&quot;: { &quot;click&quot;: false, &quot;hover&quot;: false, &quot;focus&quot;: false }, &quot;type&quot;: &quot;submenu&quot; }\" data-wp-interactive=\"core\/navigation\" data-wp-on--focusout=\"actions.handleMenuFocusout\" data-wp-on--keydown=\"actions.handleMenuKeydown\" data-wp-on-async--mouseenter=\"actions.openMenuOnHover\" data-wp-on-async--mouseleave=\"actions.closeMenuOnHover\" data-wp-watch=\"callbacks.initMenu\" tabindex=\"-1\" class=\"has-large-font-size wp-block-navigation-item has-child open-on-hover-click wp-block-navigation-submenu\"><a class=\"wp-block-navigation-item__content\" href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/lift-design-progression\/\">Proposed Solutions<\/a><button data-wp-bind--aria-expanded=\"state.isMenuOpen\" data-wp-on-async--click=\"actions.toggleMenuOnClick\" aria-label=\"Proposed Solutions submenu\" class=\"wp-block-navigation__submenu-icon wp-block-navigation-submenu__toggle\" ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" viewBox=\"0 0 12 12\" fill=\"none\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M1.50002 4L6.00002 8L10.5 4\" stroke-width=\"1.5\"><\/path><\/svg><\/button><ul data-wp-on-async--focus=\"actions.openMenuOnFocus\" class=\"wp-block-navigation__submenu-container has-text-color has-black-color wp-block-navigation-submenu\"><li class=\"has-large-font-size wp-block-navigation-item wp-block-navigation-link has-medium-font-size\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/lift-decision-matrix\/\"><span class=\"wp-block-navigation-item__label\">Lift Decision Matrix<\/span><\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div><\/nav><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<h1 class=\"has-text-align-center wp-block-heading\">DESIGN CONTROL <\/h1>\n\n\n\n<p class=\"has-text-align-center has-black-color has-text-color\" style=\"font-size:1.5rem\">In compliance with the Food &amp; Drug Administration (FDA) and Code of Federal Regulations (CFR) Title 21, formal procedure is to be followed during development of the P.H.A.M. device.  Implementing these provided design control regulations of medical devices will establish a  methodology to ensure the intended device requirements are met. The device input and output performance will be governed by the verification and validation processes to better guarantee the quality of the device and its performance. <\/p>\n\n\n\n<p class=\"has-text-align-center\" style=\"font-size:1.5rem\">The device requirements and specifications are put in place as supplemental guidelines to aid in our development procedure.  Both the requirements and specifications are to coincide in order to build the physical device while also having it function properly. <\/p>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\" style=\"grid-template-columns:79% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"738\" src=\"http:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-05-at-3.59.53-PM-1024x738.png\" alt=\"\" class=\"wp-image-238 size-full\" srcset=\"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-05-at-3.59.53-PM-1024x738.png 1024w, https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-05-at-3.59.53-PM-300x216.png 300w, https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-05-at-3.59.53-PM-768x554.png 768w, https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-content\/uploads\/sites\/216\/2023\/02\/Screenshot-2023-02-05-at-3.59.53-PM.png 1132w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-text-align-center\"><strong>The common Waterfall Model, illustrating the relationship between design control components of medical device development. <\/strong><\/p>\n\n\n\n<div style=\"height:581px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":406,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"blank","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-237","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/pages\/237","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/users\/406"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/comments?post=237"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/pages\/237\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/relief-tech-team\/wp-json\/wp\/v2\/media?parent=237"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}