SaMD Software as a Medical Device

Blog

Medical Device License (MDL MDEL SaMD) Under the Microscope

The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device

Dillon Dubois November 15, 2022

Blog

How Does FDA Classify Software As A Medical Device (SaMD)?

Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The

Dillon Dubois September 15, 2022

Get Updates And Stay Connected -Subscribe To Our Newsletter

About us

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Compliance Solutions

Quick Links

img.wp-smiley,img.emoji{display:inline !important;border:none !important;box-shadow:none !important;height:1em !important;width:1em !important;margin:0 .07em !important;vertical-align:-.1em !important;background:none !important;padding:0 !important;}body{--wp--preset--color--black:#000;--wp--preset--color--cyan-bluish-gray:#abb8c3;--wp--preset--color--white:#fff;--wp--preset--color--pale-pink:#f78da7;--wp--preset--color--vivid-red:#cf2e2e;--wp--preset--color--luminous-vivid-orange:#ff6900;--wp--preset--color--luminous-vivid-amber:#fcb900;--wp--preset--color--light-green-cyan:#7bdcb5;--wp--preset--color--vivid-green-cyan:#00d084;--wp--preset--color--pale-cyan-blue:#8ed1fc;--wp--preset--color--vivid-cyan-blue:#0693e3;--wp--preset--color--vivid-purple:#9b51e0;--wp--preset--color--accent:#cd2653;--wp--preset--color--primary:#000;--wp--preset--color--secondary:#6d6d6d;--wp--preset--color--subtle-background:#dcd7ca;--wp--preset--color--background:#f5efe0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple:linear-gradient(135deg,rgba(6,147,227,1) 0%,#9b51e0 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan:linear-gradient(135deg,#7adcb4 0%,#00d082 100%);--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange:linear-gradient(135deg,rgba(252,185,0,1) 0%,rgba(255,105,0,1) 100%);--wp--preset--gradient--luminous-vivid-orange-to-vivid-red:linear-gradient(135deg,rgba(255,105,0,1) 0%,#cf2e2e 100%);--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray:linear-gradient(135deg,#eee 0%,#a9b8c3 100%);--wp--preset--gradient--cool-to-warm-spectrum:linear-gradient(135deg,#4aeadc 0%,#9778d1 20%,#cf2aba 40%,#ee2c82 60%,#fb6962 80%,#fef84c 100%);--wp--preset--gradient--blush-light-purple:linear-gradient(135deg,#ffceec 0%,#9896f0 100%);--wp--preset--gradient--blush-bordeaux:linear-gradient(135deg,#fecda5 0%,#fe2d2d 50%,#6b003e 100%);--wp--preset--gradient--luminous-dusk:linear-gradient(135deg,#ffcb70 0%,#c751c0 50%,#4158d0 100%);--wp--preset--gradient--pale-ocean:linear-gradient(135deg,#fff5cb 0%,#b6e3d4 50%,#33a7b5 100%);--wp--preset--gradient--electric-grass:linear-gradient(135deg,#caf880 0%,#71ce7e 100%);--wp--preset--gradient--midnight:linear-gradient(135deg,#020381 0%,#2874fc 100%);--wp--preset--duotone--dark-grayscale:url("#wp-duotone-dark-grayscale");--wp--preset--duotone--grayscale:url("#wp-duotone-grayscale");--wp--preset--duotone--purple-yellow:url("#wp-duotone-purple-yellow");--wp--preset--duotone--blue-red:url("#wp-duotone-blue-red");--wp--preset--duotone--midnight:url("#wp-duotone-midnight");--wp--preset--duotone--magenta-yellow:url("#wp-duotone-magenta-yellow");--wp--preset--duotone--purple-green:url("#wp-duotone-purple-green");--wp--preset--duotone--blue-orange:url("#wp-duotone-blue-orange");--wp--preset--font-size--small:18px;--wp--preset--font-size--medium:20px;--wp--preset--font-size--large:26.25px;--wp--preset--font-size--x-large:42px;--wp--preset--font-size--normal:21px;--wp--preset--font-size--larger:32px;--wp--preset--spacing--20:.44rem;--wp--preset--spacing--30:.67rem;--wp--preset--spacing--40:1rem;--wp--preset--spacing--50:1.5rem;--wp--preset--spacing--60:2.25rem;--wp--preset--spacing--70:3.38rem;--wp--preset--spacing--80:5.06rem;}:where(.is-layout-flex){gap:.5em;}body .is-layout-flow > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-flow > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-flow > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-constrained > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-constrained > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > :where(:not(.alignleft):not(.alignright):not(.alignfull)){max-width:var(--wp--style--global--content-size);margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignwide{max-width:var(--wp--style--global--wide-size);}body .is-layout-flex{display:flex;}body .is-layout-flex{flex-wrap:wrap;align-items:center;}body .is-layout-flex > *{margin:0;}:where(.wp-block-columns.is-layout-flex){gap:2em;}.has-black-color{color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-color{color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-color{color:var(--wp--preset--color--white) !important;}.has-pale-pink-color{color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-color{color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-color{color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-color{color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-color{color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-color{color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-color{color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-color{color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-color{color:var(--wp--preset--color--vivid-purple) !important;}.has-black-background-color{background-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color:var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color:var(--wp--preset--color--vivid-purple) !important;}.has-black-border-color{border-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color:var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color:var(--wp--preset--color--vivid-purple) !important;}.has-vivid-cyan-blue-to-vivid-purple-gradient-background{background:var(--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple) !important;}.has-light-green-cyan-to-vivid-green-cyan-gradient-background{background:var(--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan) !important;}.has-luminous-vivid-amber-to-luminous-vivid-orange-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange) !important;}.has-luminous-vivid-orange-to-vivid-red-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-orange-to-vivid-red) !important;}.has-very-light-gray-to-cyan-bluish-gray-gradient-background{background:var(--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray) !important;}.has-cool-to-warm-spectrum-gradient-background{background:var(--wp--preset--gradient--cool-to-warm-spectrum) !important;}.has-blush-light-purple-gradient-background{background:var(--wp--preset--gradient--blush-light-purple) !important;}.has-blush-bordeaux-gradient-background{background:var(--wp--preset--gradient--blush-bordeaux) !important;}.has-luminous-dusk-gradient-background{background:var(--wp--preset--gradient--luminous-dusk) !important;}.has-pale-ocean-gradient-background{background:var(--wp--preset--gradient--pale-ocean) !important;}.has-electric-grass-gradient-background{background:var(--wp--preset--gradient--electric-grass) !important;}.has-midnight-gradient-background{background:var(--wp--preset--gradient--midnight) !important;}.has-small-font-size{font-size:var(--wp--preset--font-size--small) !important;}.has-medium-font-size{font-size:var(--wp--preset--font-size--medium) !important;}.has-large-font-size{font-size:var(--wp--preset--font-size--large) !important;}.has-x-large-font-size{font-size:var(--wp--preset--font-size--x-large) !important;}.wp-block-navigation a:where(:not(.wp-element-button)){color:inherit;}:where(.wp-block-columns.is-layout-flex){gap:2em;}.wp-block-pullquote{font-size:1.5em;line-height:1.6;}.color-accent,.color-accent-hover:hover,.color-accent-hover:focus,:root .has-accent-color,.has-drop-cap:not(:focus):first-letter,.wp-block-button.is-style-outline,a{color:#cd2653;}blockquote,.border-color-accent,.border-color-accent-hover:hover,.border-color-accent-hover:focus{border-color:#cd2653;}button,.button,.faux-button,.wp-block-button__link,.wp-block-file .wp-block-file__button,input[type="button"],input[type="reset"],input[type="submit"],.bg-accent,.bg-accent-hover:hover,.bg-accent-hover:focus,:root .has-accent-background-color,.comment-reply-link{background-color:#cd2653;}.fill-children-accent,.fill-children-accent *{fill:#cd2653;}body,.entry-title a,:root .has-primary-color{color:#000;}:root .has-primary-background-color{background-color:#000;}cite,figcaption,.wp-caption-text,.post-meta,.entry-content .wp-block-archives li,.entry-content .wp-block-categories li,.entry-content .wp-block-latest-posts li,.wp-block-latest-comments__comment-date,.wp-block-latest-posts__post-date,.wp-block-embed figcaption,.wp-block-image figcaption,.wp-block-pullquote cite,.comment-metadata,.comment-respond .comment-notes,.comment-respond .logged-in-as,.pagination .dots,.entry-content hr:not(.has-background),hr.styled-separator,:root .has-secondary-color{color:#6d6d6d;}:root .has-secondary-background-color{background-color:#6d6d6d;}pre,fieldset,input,textarea,table,table *,hr{border-color:#dcd7ca;}caption,code,code,kbd,samp,.wp-block-table.is-style-stripes tbody tr:nth-child(odd),:root .has-subtle-background-background-color{background-color:#dcd7ca;}.wp-block-table.is-style-stripes{border-bottom-color:#dcd7ca;}.wp-block-latest-posts.is-grid li{border-top-color:#dcd7ca;}:root .has-subtle-background-color{color:#dcd7ca;}body:not(.overlay-header) .primary-menu > li > a,body:not(.overlay-header) .primary-menu > li > .icon,.modal-menu a,.footer-menu a,.footer-widgets a,#site-footer .wp-block-button.is-style-outline,.wp-block-pullquote:before,.singular:not(.overlay-header) .entry-header a,.archive-header a,.header-footer-group .color-accent,.header-footer-group .color-accent-hover:hover{color:#cd2653;}.social-icons a,#site-footer button:not(.toggle),#site-footer .button,#site-footer .faux-button,#site-footer .wp-block-button__link,#site-footer .wp-block-file__button,#site-footer input[type="button"],#site-footer input[type="reset"],#site-footer input[type="submit"]{background-color:#cd2653;}.header-footer-group,body:not(.overlay-header) #site-header .toggle,.menu-modal .toggle{color:#000;}body:not(.overlay-header) .primary-menu ul{background-color:#000;}body:not(.overlay-header) .primary-menu > li > ul:after{border-bottom-color:#000;}body:not(.overlay-header) .primary-menu ul ul:after{border-left-color:#000;}.site-description,body:not(.overlay-header) .toggle-inner .toggle-text,.widget .post-date,.widget .rss-date,.widget_archive li,.widget_categories li,.widget cite,.widget_pages li,.widget_meta li,.widget_nav_menu li,.powered-by-wordpress,.to-the-top,.singular .entry-header .post-meta,.singular:not(.overlay-header) .entry-header .post-meta a{color:#6d6d6d;}.header-footer-group pre,.header-footer-group fieldset,.header-footer-group input,.header-footer-group textarea,.header-footer-group table,.header-footer-group table *,.footer-nav-widgets-wrapper,#site-footer,.menu-modal nav *,.footer-widgets-outer-wrapper,.footer-top{border-color:#dcd7ca;}.header-footer-group table caption,body:not(.overlay-header) .header-inner .toggle-wrapper::before{background-color:#dcd7ca;}.goog-te-gadget{color:transparent !important;margin-top:2px;height:21px;}.single-post ul{margin-left:0px;margin-bottom:20px;}@media (max-width: 420px){.elementor-element-75e02145 ul.elementor-icon-list-items.elementor-inline-items{display:block;margin:0px 10px !important;}.elementor-element-75e02145 ul.elementor-icon-list-items.elementor-inline-items li:nth-child(1){float:left;}.elementor-element-75e02145 ul.elementor-icon-list-items.elementor-inline-items li:nth-child(2){float:right;}}.recentcomments a{display:inline !important;padding:0 !important;margin:0 !important;}.npf{display:none !important;}a.elementor-post-info__terms-list-item{text-transform:uppercase !important;}.aiosrs-rating-wrap{display:none !important;}#elementor-popup-modal-15292 .dialog-close-button i{display:none !important;}.elementor-8117 .elementor-element.elementor-element-80252e6 a{color:#fff;}.menu-icon{margin-right:6px;}.menu-icon img{width:18px;}#sidebar_cat ul{margin-left:0px !important;}.goog-logo-link{display:none;}.single-post h3{font-size:17px !important;margin-top:10px !important;margin-bottom:5px !important;}.single-post h1{font-size:24px !important;margin-top:10px !important;margin-bottom:15px !important;}.elementor-posts .elementor-post__card .elementor-post__meta-data span+span:before{display:none;}.faq_block .elementor-accordion-icon{float:left;height:45px;margin-top:5px;}.mdsapc ul,ol{margin-bottom:20px;margin-left:10px;}.mdsapc h5{font-size:1.8rem;margin-bottom:10px !important;}.mdsapc p{margin-bottom:20px;}.title_txt a{color:#80c235;}.table_dropdown ul li a{color:#000;}.see_btn{color:#fff !important;}@media screen and (min-width:1200px){#resources_blk p{min-height:175px;}span.block{display:block;}#updates_block #title{min-height:215px;}}li.feed-item a{color:#2f69b2;}#vertical_tabs p{display:none;}#sidebar_subscrb{padding:32px 35px;background:#f3f8f3;}#sidebar_subscrb input[type=email]{border:2px solid rgba(34,34,34,.11);}#sidebar_subscrb input[type=submit]{position:relative !important;background:#61ce70;line-height:12px;border-radius:0px;margin-top:20px;font-size:16px;font-weight:500;width:100% !important;display:block;max-width:100% !important;}#vertical_tabs .elementor-tabs-wrapper{border-right:4px solid #61ce70;}#vertical_tabs .elementor-tab-desktop-title{background:#f9f9f9;border-bottom:2px solid #fff;}#vertical_tabs .elementor-tabs-content-wrapper{border:0px solid;}#vertical_tabs .elementor-tabs-wrapper .elementor-active{background:#61ce70;}#vertical_tabs .elementor-tabs-wrapper .elementor-active a{color:#fff;}.elementor-post-author{}.elementor-post__meta-data{background:#f8f8f8;}.elementor-post__category{display:block;width:100%;padding-top:10px;}.elementor-post-date{float:right;}hr.styled-separator.pagination-separator.is-style-wide{display:none;}h2.vtabs_title{color:#2f69b2;font-family:"Montserrat",Sans-serif;font-size:28px;font-weight:600;text-transform:uppercase;margin-top:25px;margin-bottom:16px;padding-left:5px;}.slick-slider .elementor-swiper-button{color:#000 !important;opacity:.5;}.slick-slider .elementor-swiper-button-prev{left:-25px;}.slick-slider .elementor-swiper-button-next{right:-25px;}li.cat-item a{color:#000;}li.cat-item{font-size:15px;color:#2575fc;list-style:square;}.single.single-post .elementor-widget-wp-widget-categories ul{margin:0px;}.custom-search{max-width:600px;box-shadow:0px 0px 5px rgba(0,0,0,10%);margin-left:auto;margin-right:auto;}.custom-search input{padding-left:10px !important;}.custom-search .elementor-search-form__submit{width:60px;background:#54b962;}.news-main-sec.elementor-section.elementor-section-boxed.elementor-container{max-width:1400px;display:flex;margin-right:auto;margin-left:auto;position:relative;}.news-main-sec.elementor-section.elementor-section-boxed.elementor-container{padding:40px 20px 20px 20px;}.archive main#site-content{background:#fff;}.elementor-post-info__terms-list a{text-transform:capitalize;}.elementor-post__excerpt p{display:inline;}.elementor-post__excerpt a{color:#61ce70;font-family:"Open Sans",Sans-serif;font-size:16px;font-weight:400;}.elementor-post__excerpt{margin:0;line-height:1.5em;font-size:14px;color:#777;margin-bottom:20px !important;}a.elementor-post__read-more{border-radius:30px;color:#000 !important;font-size:13px !important;}form.category_filter select{border:1px solid #ccc;padding:10px 10px;color:#252525;font-size:16px;}form.category_filter{float:right;}.slider-post .slick-slide{margin:0 12px;}.slider-post .slick-list{margin:0 -12px;}th,td{font-size:16px;}#mc4wp-form-1 input[type="submit"]{font-family:"Montserrat",Sans-serif;font-size:20px;font-weight:400;text-transform:none;border-radius:4px 4px 4px 4px;padding:12px 20px 12px 20px;margin:0px 0px 0px 0px;color:#fff;background-color:#011640;position:absolute;top:0;right:0;height:51px;max-width:200px;width:100%;}.tabs_data{list-style-type:none;}.tabs_data li{width:48%;float:left;background:#fff;margin-left:0px;display:inline-block;text-align:center;margin:0px 1%;border-radius:5px;margin-bottom:15px;}.tabs_data li a{color:#003;font-weight:600;display:block;padding:20px 10px;}.tabs_data li a:hover{color:#61ce70;}#vert_tabs .elementor-tabs-wrapper{border-right:2px solid #61ce70;}#vert_tabs .elementor-tab-title.elementor-active{background:#61ce70;color:#fff;}#vert_tabs .elementor-tab-title.elementor-active a{color:#fff;}#vert_tabs .elementor-tab-title a{color:#003;display:block;}#infographics .elementskit-info-box-title{height:40px;}#vert_tabs .elementor-tabs-content-wrapper{box-shadow:0px 0px 20px rgba(0,0,0,4%);}.single-post .post-con .elementor-text-editor.elementor-clearfix{color:#000;}.elementor-element.elementor-element-6c1c0471.elementor-widget.elementor-widget-html iframe{width:470px !important;}@media screen and (max-width:767px){.elementskit-submenu-panel{padding-top:10px !important;padding-bottom:10px !important;}.elementskit-submenu-panel li a{padding-top:10px !important;padding-bottom:5px !important;}#mc4wp-form-1 input[type="submit"]{position:relative !important;max-width:100% !important;width:100% !important;}.elementor-51 .elementor-element.elementor-element-336cbff4 .elementskit-testimonial-slider .slick-dots{bottom:0px;display:block !important;}#launcher{width:150px !important;}.tabs_data{margin-left:0px;}.tabs_data li a{font-size:12px;min-height:95px;}#vert_tabs .elementor-tab-title a{color:#003;display:block;}#vert_tabs .elementor-tab-mobile-title{color:#003;display:block;}.tabs_data li{margin-bottom:7px;}#icon_shop .icon-online-shopping-cart{top:-220px;right:-10px;}.elementor-126 .elementor-element.elementor-element-bcdd78d > .elementor-element-populated,.elementor-126 .elementor-element.elementor-element-6da3d08 > .elementor-element-populated,.elementor-126 .elementor-element.elementor-element-b08b297 > .elementor-element-populated,.elementor-126 .elementor-element.elementor-element-1f7062c > .elementor-element-populated,.elementor-126 .elementor-element.elementor-element-b08b297 > .elementor-element-populated{padding:0px !important;margin-top:10px !important;margin-left:-5px !important;}.elementor-629 .elementor-element.elementor-element-d1ff2a3{padding:0px;margin:0px;}body:not(.rtl) .elementor-629 .elementor-element.elementor-element-31f9451{right:7px;width:140px !important;max-width:135px;}.elementor-element.elementor-element-6c1c0471.elementor-widget.elementor-widget-html iframe{width:470px !important;}}.box-body{font-size:16px !important;color:#565656;font-family:"Open Sans",Sans-serif !important;font-weight:400;}.box-body .elementskit-info-box-title{margin-bottom:8px !important;}@media screen and (max-width:1320px) and (min-width:1280px){#icon_shop .icon-online-shopping-cart{right:0px;}}.elementor-widget-image{text-align:center;}.elementor-widget-image a{display:inline-block;}.elementor-widget-image a img[src$=".svg"]{width:48px;}.elementor-widget-image img{vertical-align:middle;display:inline-block;}.elementor-heading-title{padding:0;margin:0;line-height:1;}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit;}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px;}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px;}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px;}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px;}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px;}.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff;}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;border:3px solid;background-color:transparent;}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px;}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em;}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px;}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block;}.elementor-widget-social-icons.elementor-grid-0 .elementor-widget-container,.elementor-widget-social-icons.elementor-grid-mobile-0 .elementor-widget-container,.elementor-widget-social-icons.elementor-grid-tablet-0 .elementor-widget-container{line-height:1;font-size:0;}.elementor-widget-social-icons:not(.elementor-grid-0):not(.elementor-grid-tablet-0):not(.elementor-grid-mobile-0) .elementor-grid{display:inline-grid;}.elementor-widget-social-icons .elementor-grid{grid-column-gap:var(--grid-column-gap,5px);grid-row-gap:var(--grid-row-gap,5px);grid-template-columns:var(--grid-template-columns);justify-content:var(--justify-content,center);justify-items:var(--justify-content,center);}.elementor-icon.elementor-social-icon{font-size:var(--icon-size,25px);line-height:var(--icon-size,25px);width:calc(var(--icon-size,25px) + ( 2 * var(--icon-padding,.5em) ));height:calc(var(--icon-size,25px) + ( 2 * var(--icon-padding,.5em) ));}.elementor-social-icon{--e-social-icon-icon-color:#fff;display:inline-flex;background-color:#818a91;align-items:center;justify-content:center;text-align:center;cursor:pointer;}.elementor-social-icon i{color:var(--e-social-icon-icon-color);}.elementor-social-icon svg{fill:var(--e-social-icon-icon-color);}.elementor-social-icon:last-child{margin:0;}.elementor-social-icon:hover{opacity:.9;color:#fff;}.elementor-social-icon-android{background-color:#a4c639;}.elementor-social-icon-apple{background-color:#999;}.elementor-social-icon-behance{background-color:#1769ff;}.elementor-social-icon-bitbucket{background-color:#205081;}.elementor-social-icon-codepen{background-color:#000;}.elementor-social-icon-delicious{background-color:#39f;}.elementor-social-icon-deviantart{background-color:#05cc47;}.elementor-social-icon-digg{background-color:#005be2;}.elementor-social-icon-dribbble{background-color:#ea4c89;}.elementor-social-icon-elementor{background-color:#d30c5c;}.elementor-social-icon-envelope{background-color:#ea4335;}.elementor-social-icon-facebook,.elementor-social-icon-facebook-f{background-color:#3b5998;}.elementor-social-icon-flickr{background-color:#0063dc;}.elementor-social-icon-foursquare{background-color:#2d5be3;}.elementor-social-icon-free-code-camp,.elementor-social-icon-freecodecamp{background-color:#006400;}.elementor-social-icon-github{background-color:#333;}.elementor-social-icon-gitlab{background-color:#e24329;}.elementor-social-icon-globe{background-color:#818a91;}.elementor-social-icon-google-plus,.elementor-social-icon-google-plus-g{background-color:#dd4b39;}.elementor-social-icon-houzz{background-color:#7ac142;}.elementor-social-icon-instagram{background-color:#262626;}.elementor-social-icon-jsfiddle{background-color:#487aa2;}.elementor-social-icon-link{background-color:#818a91;}.elementor-social-icon-linkedin,.elementor-social-icon-linkedin-in{background-color:#0077b5;}.elementor-social-icon-medium{background-color:#00ab6b;}.elementor-social-icon-meetup{background-color:#ec1c40;}.elementor-social-icon-mixcloud{background-color:#273a4b;}.elementor-social-icon-odnoklassniki{background-color:#f4731c;}.elementor-social-icon-pinterest{background-color:#bd081c;}.elementor-social-icon-product-hunt{background-color:#da552f;}.elementor-social-icon-reddit{background-color:#ff4500;}.elementor-social-icon-rss{background-color:#f26522;}.elementor-social-icon-shopping-cart{background-color:#4caf50;}.elementor-social-icon-skype{background-color:#00aff0;}.elementor-social-icon-slideshare{background-color:#0077b5;}.elementor-social-icon-snapchat{background-color:#fffc00;}.elementor-social-icon-soundcloud{background-color:#f80;}.elementor-social-icon-spotify{background-color:#2ebd59;}.elementor-social-icon-stack-overflow{background-color:#fe7a15;}.elementor-social-icon-steam{background-color:#00adee;}.elementor-social-icon-stumbleupon{background-color:#eb4924;}.elementor-social-icon-telegram{background-color:#2ca5e0;}.elementor-social-icon-thumb-tack{background-color:#1aa1d8;}.elementor-social-icon-tripadvisor{background-color:#589442;}.elementor-social-icon-tumblr{background-color:#35465c;}.elementor-social-icon-twitch{background-color:#6441a5;}.elementor-social-icon-twitter{background-color:#1da1f2;}.elementor-social-icon-viber{background-color:#665cac;}.elementor-social-icon-vimeo{background-color:#1ab7ea;}.elementor-social-icon-vk{background-color:#45668e;}.elementor-social-icon-weibo{background-color:#dd2430;}.elementor-social-icon-weixin{background-color:#31a918;}.elementor-social-icon-whatsapp{background-color:#25d366;}.elementor-social-icon-wordpress{background-color:#21759b;}.elementor-social-icon-xing{background-color:#026466;}.elementor-social-icon-yelp{background-color:#af0606;}.elementor-social-icon-youtube{background-color:#cd201f;}.elementor-social-icon-500px{background-color:#0099e5;}.elementor-shape-rounded .elementor-icon.elementor-social-icon{border-radius:10%;}.elementor-shape-circle .elementor-icon.elementor-social-icon{border-radius:50%;}

SaMD Software as a Medical Device

Medical Device License (MDL MDEL SaMD) Under the Microscope

How Does FDA Classify Software As A Medical Device (SaMD)?

Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.