{"id":2223,"date":"2024-01-03T08:30:15","date_gmt":"2024-01-03T07:30:15","guid":{"rendered":"https:\/\/www.bayoomed.com\/begleitprozesse\/technical-documentation\/"},"modified":"2026-07-24T10:53:57","modified_gmt":"2026-07-24T08:53:57","slug":"technical-documentation","status":"publish","type":"begleitprozesse","link":"https:\/\/www.bayoomed.com\/en\/begleitprozesse\/technical-documentation\/","title":{"rendered":"Technical Documentation for Medical Devices"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 70vw + 0px );margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:0px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:39;line-height:var(--awb-typography1-line-height);\"><h2>Technical documentation &#8211; the core of your medical device<\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-1\"><p>Do you recognize any of these scenarios? <span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\">You have just received a list of deficiencies from your Notified Body or the FDA and don&#8217;t know what they are talking about and what you should do next? Or <\/span><span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\"> Is your technical documentation a mess or does it just need an update for the MDR or IVDR?<\/span><\/p>\n<p>If you&#8217;re under pressure, you don&#8217;t need good advice. What you really need is someone who gets things done. And that&#8217;s exactly what our quality experts do. We are also happy to support you in preparing your technical documentation and files for software-based medical devices.   <\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 70vw + );margin-left: calc(- \/ 2 );margin-right: calc(- \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-margin-bottom-large:20px;--awb-width-medium:20%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-hand-holding-medical fas circle-yes\" style=\"--awb-circlebordersize:0px;--awb-font-size:70.4px;--awb-width:140.8px;--awb-height:140.8px;--awb-line-height:140.8px;--awb-margin-top:0;--awb-margin-right:0;--awb-margin-bottom:0;--awb-margin-left:0;--awb-align-self:center;\"><\/i><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-padding-top:60px;--awb-padding-right:60px;--awb-padding-bottom:60px;--awb-padding-left:60px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color7);--awb-bg-color-hover:var(--awb-color7);--awb-bg-size:cover;--awb-border-radius:60px 60px 60px 60px;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-margin-bottom-large:60px;--awb-spacing-left-large:calc( 0 * calc( 100% - ) );--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-left-medium:calc( 0 * calc( 100% - ) );--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:0px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\"><h3>Why you don&#8217;t have to worry about the technical documentation?<\/h3><\/h3><\/div><div class=\"fusion-text fusion-text-2\"><\/p>\n<p><span style=\"color: var(--awb-color1);\">Because we know what matters when it comes to creating technical documentation. Our teams have already supported over 30 medical software and app projects and various conformity assessment procedures   <\/span><span style=\"color: var(--awb-color1); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-small);\">and FDA approvals. And it is precisely with this expertise that we would like to help you and your technical documentation for your medical device move forward. <\/span><\/p><\/p>\n<\/div><div style=\"text-align:left;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--awb-margin-top:20px;--button-border-radius-top-left:30px;--button-border-radius-top-right:30px;--button-border-radius-bottom-right:30px;--button-border-radius-bottom-left:30px;\" target=\"_self\" href=\"https:\/\/www.bayoomed.com\/en\/#contact\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">contact now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>","protected":false},"featured_media":1430,"template":"","categories":[35,33],"class_list":["post-2223","begleitprozesse","type-begleitprozesse","status-publish","has-post-thumbnail","hentry","category-medtech-en","category-service"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.3 (Yoast SEO v28.3) - 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