{"id":31166,"date":"2025-03-04T11:03:48","date_gmt":"2025-03-04T11:03:48","guid":{"rendered":"https:\/\/elosmedtech.com\/medical-polymer-solutions\/injection-molding-copy\/"},"modified":"2026-08-06T16:15:50","modified_gmt":"2026-08-06T16:15:50","slug":"validation-of-medical-devices","status":"publish","type":"page","link":"https:\/\/elosmedtech.com\/de\/sterile-packaging-solutions\/validation-of-medical-devices\/","title":{"rendered":"Medical Device Validation"},"content":{"rendered":"<!--themify_builder_content-->\n<div id=\"themify_builder_content-31166\" data-postid=\"31166\" class=\"themify_builder_content themify_builder_content-31166 themify_builder tf_clear\">\n                    <div  data-css_id=\"rjyi606\" data-lazy=\"1\" class=\"module_row themify_builder_row fullwidth tb_rjyi606 tb_first tf_w\">\n                        <div class=\"row_inner col_align_top tb_col_count_2 tf_box tf_rel\">\n                        <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_sqhf455 intro-column first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_c06k405\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_96m4503 first\">\n                    <!-- Breadcrumbs module -->\n<div  class=\"module module-breadcrumbs tb_8azz830\" data-lazy=\"1\" id=\"top-2-2-2\">\n\t<nav role=\"navigation\" aria-label=\"Breadcrumbs\" class=\"tbp_breadcrumb_trail\"><ul class=\"tbp_trail_items\" itemscope itemtype=\"http:\/\/schema.org\/BreadcrumbList\"><meta name=\"numberOfItems\" content=\"1\" \/><meta name=\"itemListOrder\" content=\"Ascending\" \/><li itemprop=\"itemListElement\" itemscope itemtype=\"https:\/\/schema.org\/ListItem\" class=\"tbp_trail_item tbp_trail_end\"><a itemprop=\"item\" href=\"https:\/\/elosmedtech.com\/de\/\" rel=\"home\"><span itemprop=\"name\">Home<\/span><\/a><meta itemprop=\"position\" content=\"1\" \/><\/li><\/ul><\/nav><\/div><!-- \/Breadcrumbs module -->\n<!-- module plain text -->\n<div  class=\"module module-plain-text tb_2e9x080\" data-lazy=\"1\">\n        <div class=\"tb_text_wrap\">\n        <\/div>\n<\/div>\n<!-- \/module plain text -->        <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_7vrm440\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_btyp080 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_acb4000    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h1>Medical Device Validation Services<\/h1>    <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div  class=\"module module-text tb_bxq5400\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h5>Our validation program design and execution services for cleaning, packaging and sterilization. We also offer quality assurance support and regulatory consultations.<\/h5>    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_mxl6350 last\">\n        <span class=\"tb_row_frame_wrap tf_overflow tf_abs\" data-lazy=\"1\"><span class=\"tb_row_frame tb_row_frame_bottom  tf_abs tf_hide tf_overflow tf_w\"><\/span><span class=\"tb_row_frame tb_row_frame_left  tf_abs tf_hide tf_overflow tf_h\"><\/span><\/span>                    <\/div>\n                        <\/div>\n        <\/div>\n                        <div  data-lazy=\"1\" class=\"module_row themify_builder_row tb_o0h9001 tf_w\">\n                        <div class=\"row_inner col_align_middle tb_col_count_2 tf_box tf_rel\">\n                        <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_2q1j640 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_5vjr191\" data-lazy=\"1\" data-sticky-active=\"{&quot;d&quot;:{&quot;stick&quot;:{&quot;v&quot;:&quot;200&quot;},&quot;unstick&quot;:{&quot;type&quot;:&quot;row&quot;,&quot;el&quot;:&quot;hv9n303&quot;}},&quot;m&quot;:0}\">\n        <div  class=\"tb_text_wrap\">\n        <div class=\"elementToProof\">\n<div class=\"elementToProof\"><a data-tb-inline-nav=\"#top\">Validation Strategy &amp; QA<\/a><\/div>\n<\/div>\n<div>&nbsp;<\/div><div><a href=\"#consulting\">Validation &amp; Quality Consulting<\/a><\/div>\n<div class=\"elementToProof\">\n<div class=\"elementToProof\">&nbsp;<\/div>\n<\/div>\n<div><a href=\"#cleaning\">Cleaning Validation Tests<\/a><\/div><div><br><\/div><div><a data-tb-inline-nav=\"#packagingtests\">Packaging Validation Tests<\/a><\/div><br class=\"Apple-interchange-newline\"><span style=\"color: rgb(255, 71, 71);\"><a href=\"#sterilization\">Sterilization Validation<\/a>&nbsp;Test<\/span><div><br><\/div><div><br><\/div><div><br><\/div>\n<div><a href=\"#top\">Back to top<\/a><\/div>    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_md4y522 last\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_middle tb_col_count_2 tb_jj2q003\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_bym4440 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_de9u588\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_v2go686 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_9es6686\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_6wkm686 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_6a26686    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Validation Strategy &amp; Quality Assurance<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_2bj9686\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_0dvd686 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_9xcj686\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">With extensive experience in validation program design and execution, we support targeted, cost-efficient validation strategies to confirm your product\u2019s key properties while optimizing time and resources.<\/p>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We support:<\/p>\n<ul>\n<li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Validation plan definition<\/li>\n<li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Organizing and executing validation activities<\/li><li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Quality Assurance management<\/li>\n<\/ul>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Our medical device validations are conducted in-house or in collaboration with expert partners. Our quality assurance expertise covers everything from audits and CAPA management to handling defective products and customer complaints.<\/p>    <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div  class=\"module module-image tb_lpg4300 image-top   tf_mw\" data-lazy=\"1\">\n        <div class=\"image-wrap tf_rel tf_mw\">\n            <img loading=\"lazy\" decoding=\"async\" width=\"1500\" height=\"1000\" src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp\" class=\"wp-post-image wp-image-24249\" title=\"Services - Sterilization Management\" alt=\"\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp 1500w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-300x200.webp 300w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-1024x683.webp 1024w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-768x512.webp 768w\" sizes=\"auto, (max-width: 1500px) 100vw, 1500px\" \/>    \n        <\/div>\n    <!-- \/image-wrap -->\n    \n        <\/div>\n<!-- \/module image -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_bf0i220\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_g7bn220 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_h9i7220\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_89f6220 first\">\n                    <!-- module divider -->\n<div  class=\"module tf_mw module-divider tb_a60n927 solid\" style=\"border-width: 0px;margin-bottom: 100px;\" data-lazy=\"1\">\n    <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div  class=\"module module-text tb_8h0v221    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Comprehensive Validation Services<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_m85j220\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_v6ks220 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_giu7221\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We cover all key validation areas, helping you demonstrate conformity, efficiency, and safety for medical device approval:<\/p>\n<ul>\n<li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><b><b>Cleaning validation<\/b> <\/b>\u2013 Verifying product cleanliness and biocompatibility<\/li>\n<li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><span style=\"font-weight: bold;\">Packaging validation <\/span>\u2013 Ensuring sterility and product protection<\/li>\n<li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><span style=\"font-weight: bold;\">Sterilization validation<\/span> \u2013 Confirming effective microbial elimination<\/li>\n<\/ul>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">All packaging validation tests are available as in-house services, including Operational Qualification (OQ), Performance Qualification (PQ) and shelf-life determination.<\/p><p><\/p>\n    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_makk869\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_aygl869 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_3np9869\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_7t9p869 first\">\n                    <!-- module divider -->\n<div  class=\"module tf_mw module-divider tb_5524667 solid\" style=\"border-width: 0px;margin-bottom: 100px;\" data-lazy=\"1\" id=\"consulting\">\n    <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div  class=\"module module-text tb_72wp869    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Expert Validation and Quality Consulting<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_zq31869\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_67hw869 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_c9xb869\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">With our expertise, we support not just validation execution, but also the development of an efficient quality system.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We offer:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><ul><li>Consulting on all quality-related matters<\/li><li>Support for product approvals<\/li><li>Validation program planning &amp; test execution<\/li><li>Organization of all validation activities<\/li><li>In-house packaging testing<\/li><\/ul><\/p><p><\/p>\n    <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div  class=\"module module-image tb_lrmt869 image-top   tf_mw\" data-lazy=\"1\">\n        <div class=\"image-wrap tf_rel tf_mw\">\n            <img loading=\"lazy\" decoding=\"async\" width=\"1500\" height=\"1024\" src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging.webp\" class=\"wp-post-image wp-image-24246\" title=\"Services - Sterile Packaging\" alt=\"\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging.webp 1500w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-300x205.webp 300w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-1024x699.webp 1024w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-768x524.webp 768w\" sizes=\"auto, (max-width: 1500px) 100vw, 1500px\" \/>    \n        <\/div>\n    <!-- \/image-wrap -->\n    \n        <\/div>\n<!-- \/module image -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_vipc201\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_lh9l201 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_e320201\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_w0yw201 first\">\n                    <!-- module divider -->\n<div  class=\"module tf_mw module-divider tb_kdfd925 solid\" style=\"border-width: 0px;margin-bottom: 100px;\" data-lazy=\"1\" id=\"cleaning\">\n    <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div  class=\"module module-text tb_ydlh201    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Cleaning Validation<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_7xil201\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_4jgt201 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_ceyh201\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Ensures that your devices are free from contaminants, including residues from manufacturing processes and microbiological contamination.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Common cleaning validation tests include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li><span style=\"font-weight: bold;\">LAL Endotoxin Test<\/span> \u2013 Detecting bacterial endotoxins<\/li><li><span style=\"font-weight: bold;\">Bacterial count determination<\/span> \u2013 Assessing microbial contamination<\/li><li><span style=\"font-weight: bold;\">Cytotoxicity test<\/span> \u2013 Evaluating biocompatibility<\/li><li><span style=\"font-weight: bold;\">Particle test <\/span>\u2013 Measuring particulate contamination<\/li><\/ul><p><\/p><p><\/p>\n    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_v6r6137\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_jwkd137 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_gdf6137\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_vety137 first\">\n                    <!-- module divider -->\n<div  class=\"module tf_mw module-divider tb_k3ww243 solid\" style=\"border-width: 0px;margin-bottom: 100px;\" data-lazy=\"1\" id=\"packagingtests\">\n    <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div  class=\"module module-text tb_0clr137    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Medical Device Packaging Validation<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_4lor137\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_5y18137 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_5nub137\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We provide packaging validation tests to guarantee the defined shelf life of your product, ensuring that sterility is not compromised during packaging, storage, and transport.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Validation tests include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li><span style=\"font-weight: bold;\">OQ (Operational Qualification)<\/span> \u2013 Establishing sealing parameters<\/li><li><span style=\"font-weight: bold;\">Shelf-life determination<\/span> \u2013 Verifying packaging integrity over time<\/li><li><span style=\"font-weight: bold;\">PQ (Performance Qualification)<\/span> \u2013 Proving process stability<\/li><li><span style=\"font-weight: bold;\">Transport validation <\/span>\u2013 Ensuring packaging durability during shipping<\/li><\/ul><p><\/p><p><\/p><p><\/p>\n    <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div  class=\"module module-image tb_alc6137 image-top   tf_mw\" data-lazy=\"1\">\n        <div class=\"image-wrap tf_rel tf_mw\">\n            <img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"512\" src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation.jpg\" class=\"wp-post-image wp-image-32457\" title=\"Validation of medical device packaging.\" alt=\"Validation of medical device packaging.\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation.jpg 768w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation-300x200.jpg 300w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/>    \n        <\/div>\n    <!-- \/image-wrap -->\n    \n        <\/div>\n<!-- \/module image -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_b6th215\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_zuer215 first\">\n                            <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_dodi215\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_b9dk215 first\">\n                    <!-- module divider -->\n<div  class=\"module tf_mw module-divider tb_a58646 solid\" style=\"border-width: 0px;margin-bottom: 100px;\" data-lazy=\"1\" id=\"sterilization\">\n    <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div  class=\"module module-text tb_ssy4215    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Sterilization Validation<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_p6sp215\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_xbxl215 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_xwrs215\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We use various sterilization methods\u2014including gamma radiation and ethylene oxide (EtO), depending on the product requirements \u2014 to achieve a Sterility Assurance Level (SAL) of 10\u207b\u2076.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Our sterilization validation services include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li>Consultation on selecting the right sterilization process<\/li><li>Support in defining and executing sterilization validation<\/li><li>Regulatory compliance guidance for global approval<\/li><\/ul><p><\/p><p><\/p><p><\/p><p><\/p>\n    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <\/div>\n                <\/div>\n                    <div  data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_d0e4013 last\">\n                            <\/div>\n                    <\/div>\n                <\/div>\n                        <\/div>\n        <\/div>\n                        <div  id=\"Anchor\" data-lazy=\"1\" class=\"module_row themify_builder_row tb_hv9n303 tf_w\">\n                        <div class=\"row_inner col_align_top tb_col_count_1 tf_box tf_rel\">\n                        <div  data-lazy=\"1\" class=\"module_column tb-column col-full tb_wina011 first\">\n                            <\/div>\n                        <\/div>\n        <\/div>\n                        <div  data-lazy=\"1\" class=\"module_row themify_builder_row tb_m2j2401 tf_w\">\n                        <div class=\"row_inner col_align_top tb_col_count_2 tf_box tf_rel\">\n                        <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_s41u385 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_0nt1505    wow\" data-tf-animation=\"fadeIn\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <h2 class=\"p1\">Comprehensive solutions for medical device validation.<\/h2>    <\/div>\n<\/div>\n<!-- \/module text -->        <div  data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_d5u5403 hide-mobile\">\n                <div  data-lazy=\"1\" class=\"module_column sub_column col-full tb_pd40513 first\">\n                    <!-- module text -->\n<div  class=\"module module-text tb_nahj541\" data-lazy=\"1\">\n        <div  class=\"tb_text_wrap\">\n        <p>We ensure that your medical device validation process is efficient, compliant, and tailored to your product needs.<\/p>\n<p>Tell us what you need\u2014we\u2019re ready to help you move forward.<\/p>    <\/div>\n<\/div>\n<!-- \/module text -->        <\/div>\n                    <\/div>\n                <\/div>\n                    <div  data-lazy=\"1\" class=\"module_column tb-column col4-2 tb_bie6544 last\">\n                    <!-- module template_part -->\n<div  class=\"module module-layout-part tb_qaqh430\">\n    <div class=\"tb_layout_part_wrap tf_w\"><!--themify_builder_content-->\n    <div  class=\"themify_builder_content themify_builder_content-26579 themify_builder not_editable_builder in_the_loop\" data-postid=\"26579\">\n                        <div  data-lazy=\"1\" class=\"module_row themify_builder_row tb_lioz600 tf_w\">\n                        <div class=\"row_inner col_align_top tb_col_count_1 tf_box tf_rel\">\n                        <div  data-lazy=\"1\" class=\"module_column tb-column col-full tb_1rab202 first\">\n                    <!-- module contact -->\n<div  id=\"tb_c4p5991\" class=\"module module-contact tb_c4p5991 contact-style2\" data-lazy=\"1\">\n    \n\t<form class=\"builder-contact\"\n\t\tid=\"tb_c4p5991-form\"\n\t\tmethod=\"post\"\n\t\tdata-post-id=\"26579\"\n\t\tdata-element-id=\"c4p5991\"\n\t\tdata-orig-id=\"31166\" action=\"\"\n\t>\n    <div class=\"contact-message\"><\/div>\n\t<input type=\"hidden\" id=\"bc_nonce\" name=\"bc_nonce\" value=\"68380654a7\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/de\/wp-json\/wp\/v2\/pages\/31166\" \/>\t<div class=\"builder-contact-fields tf_rel\">\n\t\t    \t\t    <div class=\"builder-contact-field builder-contact-field-name builder-contact-text-field\">\n\t\t\t    \t\t\t    <label class=\"control-label\" for=\"tb_c4p5991-contact-name\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"tb-label-span\">Full Name <\/span><span class=\"required\">*<\/span>\t\t\t\t<\/label>\n\t\t\t    \t\t\t    <div class=\"control-input tf_rel\">\n\t\t\t\t    \t\t\t\t\t    <input type=\"text\" name=\"contact-name\" placeholder=\"\" id=\"tb_c4p5991-contact-name\" value=\"\" class=\"form-control\" required>\n\t\t\t\t    \t\t\t    <\/div>\n\t\t<\/div>\n\t    \n\t\t    \t\t    <div class=\"builder-contact-field builder-contact-field-email builder-contact-text-field\">\n\t\t\t    \t\t\t    <label class=\"control-label\" for=\"tb_c4p5991-contact-email\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"tb-label-span\">Email <\/span><span class=\"required\">*<\/span>\t\t\t\t<\/label>\n\t\t\t    \t\t\t    <div class=\"control-input tf_rel\">\n\t\t\t\t    \t\t\t\t\t    <input type=\"email\" name=\"contact-email\" placeholder=\"\" id=\"tb_c4p5991-contact-email\" value=\"\" class=\"form-control\" required>\n\t\t\t\t    \t\t\t    <\/div>\n\t\t<\/div>\n\t    \n\t\t    \t\t    <div class=\"builder-contact-field builder-contact-field-subject builder-contact-text-field\">\n\t\t\t    \t\t\t    <label class=\"control-label\" for=\"tb_c4p5991-contact-subject\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"tb-label-span\">Subject <\/span><span class=\"required\">*<\/span>\t\t\t\t<\/label>\n\t\t\t    \t\t\t    <div class=\"control-input tf_rel\">\n\t\t\t\t    \t\t\t\t\t    <input type=\"text\" name=\"contact-subject\" placeholder=\"\" id=\"tb_c4p5991-contact-subject\" value=\"\" class=\"form-control\" required>\n\t\t\t\t    \t\t\t    <\/div>\n\t\t<\/div>\n\t    \n\t\t    \t\t    <div class=\"builder-contact-field builder-contact-field-message builder-contact-textarea-field\">\n\t\t\t    \t\t\t    <label class=\"control-label\" for=\"tb_c4p5991-contact-message\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"tb-label-span\">Message <\/span>\t\t\t\t<\/label>\n\t\t\t    \t\t\t    <div class=\"control-input tf_rel\">\n\t\t\t\t    \t\t\t\t\t    <textarea name=\"contact-message\" placeholder=\"\" id=\"tb_c4p5991-contact-message\" class=\"form-control\"><\/textarea>\n\t\t\t\t    \t\t\t    <\/div>\n\t\t<\/div>\n\t    \n\t\t    \t\t\n\t\t\t\t\t<div class=\"builder-contact-field builder-contact-field-gdpr\">\n\t\t\t\t<div class=\"control-label\">\n\t\t\t\t\t<div class=\"control-input tf_rel\">\n\t\t\t\t\t\t<label class=\"field-gdpr\">\n\t\t\t\t\t\t\t<input type=\"checkbox\" name=\"gdpr\" value=\"1\" required>\n\t\t\t\t\t\t\t<span>I consent to my submitted data being collected and stored. View Elos Medtech's <a href=\"\/de\/privacy\/\">privacy policy.<\/a><\/span>\n\t\t\t\t\t\t\t<span class=\"required\">*<\/span>\n\t\t\t\t\t\t<\/label>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\n\t    \n\t    <div class=\"builder-contact-field builder-contact-field-send control-input tf_textl tf_clear tf_rel\">\n\t\t\t<button type=\"submit\" class=\"btn btn-primary\">\n\t\t\t\t<span class=\"tf_loader\"><\/span>\t\t\t\t<span class=\"tf_submit_icon\"><\/span> \n\t\t\t\tSend\t\t\t<\/button>\n\t    <\/div>\n\t<\/div>\n    <input type=\"hidden\" name=\"trp-form-language\" value=\"de\"\/><\/form>\n    <\/div>\n<!-- \/module contact -->\n        <\/div>\n                        <\/div>\n        <\/div>\n            <\/div>\n<!--\/themify_builder_content--><\/div>\n<\/div>\n<!-- \/module template_part -->        <\/div>\n                        <\/div>\n        <\/div>\n        <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>Medical Device Validation Services<\/p>","protected":false},"author":58,"featured_media":0,"parent":32448,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"categories":[1170],"tags":[],"class_list":["post-31166","page","type-page","status-publish","hentry","category-sterile-packaging","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Validation | Elos Medtech<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/elosmedtech.com\/de\/sterile-packaging-solutions\/validation-of-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" 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Medtech","isPartOf":{"@id":"https:\/\/elosmedtech.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/#primaryimage"},"image":{"@id":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/#primaryimage"},"thumbnailUrl":"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp","datePublished":"2025-03-04T11:03:48+00:00","dateModified":"2026-08-06T16:15:50+00:00","breadcrumb":{"@id":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/#primaryimage","url":"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp","contentUrl":"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/validation-of-medical-devices\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/elosmedtech.com\/"},{"@type":"ListItem","position":2,"name":"Sterile Packaging Solutions","item":"https:\/\/elosmedtech.com\/sterile-packaging-solutions\/"},{"@type":"ListItem","position":3,"name":"Medical Device Validation"}]},{"@type":"WebSite","@id":"https:\/\/elosmedtech.com\/#website","url":"https:\/\/elosmedtech.com\/","name":"Elos Medtech","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/elosmedtech.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"}]}},"builder_content":"\n<h1>Medical Device Validation Services<\/h1>\n<h5>Our validation program design and execution services for cleaning, packaging and sterilization. We also offer quality assurance support and regulatory consultations.<\/h5>\n<a data-tb-inline-nav=\"#top\">Validation Strategy &amp; QA<\/a>\n&nbsp;<a href=\"#consulting\">Validation &amp; Quality Consulting<\/a>\n&nbsp;\n<a href=\"#cleaning\">Cleaning Validation Tests<\/a><br><a data-tb-inline-nav=\"#packagingtests\">Packaging Validation Tests<\/a><br><a href=\"#sterilization\">Sterilization Validation<\/a>&nbsp;Test<br><br><br> <a href=\"#top\">Back to top<\/a>\n<h2>Validation Strategy &amp; Quality Assurance<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">With extensive experience in validation program design and execution, we support targeted, cost-efficient validation strategies to confirm your product\u2019s key properties while optimizing time and resources.<\/p> <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We support:<\/p> <ul> <li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Validation plan definition<\/li> <li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Organizing and executing validation activities<\/li><li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Quality Assurance management<\/li> <\/ul> <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Our medical device validations are conducted in-house or in collaboration with expert partners. Our quality assurance expertise covers everything from audits and CAPA management to handling defective products and customer complaints.<\/p>\n<img src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp\" title=\"Services - Sterilization Management\" alt=\"\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management.webp 1500w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-300x200.webp 300w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-1024x683.webp 1024w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterilization-Management-768x512.webp 768w\" sizes=\"(max-width: 1500px) 100vw, 1500px\" \/>\n\n<h2>Comprehensive Validation Services<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We cover all key validation areas, helping you demonstrate conformity, efficiency, and safety for medical device approval:<\/p> <ul> <li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><b><b>Cleaning validation<\/b> <\/b>\u2013 Verifying product cleanliness and biocompatibility<\/li> <li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Packaging validation \u2013 Ensuring sterility and product protection<\/li> <li data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Sterilization validation \u2013 Confirming effective microbial elimination<\/li> <\/ul> <p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">All packaging validation tests are available as in-house services, including Operational Qualification (OQ), Performance Qualification (PQ) and shelf-life determination.<\/p><p><\/p>\n\n<h2>Expert Validation and Quality Consulting<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">With our expertise, we support not just validation execution, but also the development of an efficient quality system.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We offer:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><ul><li>Consulting on all quality-related matters<\/li><li>Support for product approvals<\/li><li>Validation program planning &amp; test execution<\/li><li>Organization of all validation activities<\/li><li>In-house packaging testing<\/li><\/ul><\/p><p><\/p>\n<img src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging.webp\" title=\"Services - Sterile Packaging\" alt=\"\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging.webp 1500w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-300x205.webp 300w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-1024x699.webp 1024w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2024\/06\/Services-Sterile-Packaging-768x524.webp 768w\" sizes=\"(max-width: 1500px) 100vw, 1500px\" \/>\n\n<h2>Cleaning Validation<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Ensures that your devices are free from contaminants, including residues from manufacturing processes and microbiological contamination.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Common cleaning validation tests include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li>LAL Endotoxin Test \u2013 Detecting bacterial endotoxins<\/li><li>Bacterial count determination \u2013 Assessing microbial contamination<\/li><li>Cytotoxicity test \u2013 Evaluating biocompatibility<\/li><li>Particle test \u2013 Measuring particulate contamination<\/li><\/ul><p><\/p><p><\/p>\n\n<h2>Medical Device Packaging Validation<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We provide packaging validation tests to guarantee the defined shelf life of your product, ensuring that sterility is not compromised during packaging, storage, and transport.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Validation tests include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li>OQ (Operational Qualification) \u2013 Establishing sealing parameters<\/li><li>Shelf-life determination \u2013 Verifying packaging integrity over time<\/li><li>PQ (Performance Qualification) \u2013 Proving process stability<\/li><li>Transport validation \u2013 Ensuring packaging durability during shipping<\/li><\/ul><p><\/p><p><\/p><p><\/p>\n<img src=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation.jpg\" title=\"Validation of medical device packaging.\" alt=\"Validation of medical device packaging.\" srcset=\"https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation.jpg 768w, https:\/\/elosmedtech.com\/wp-content\/uploads\/2025\/03\/Validation-300x200.jpg 300w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\n\n<h2>Sterilization Validation<\/h2>\n<p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">We use various sterilization methods\u2014including gamma radiation and ethylene oxide (EtO), depending on the product requirements \u2014 to achieve a Sterility Assurance Level (SAL) of 10\u207b\u2076.<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\">Our sterilization validation services include:<\/p><p data-ccp-props=\"{&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559683&quot;:0,&quot;335562764&quot;:2,&quot;335562765&quot;:1,&quot;335562766&quot;:4,&quot;335562767&quot;:0,&quot;335562768&quot;:4,&quot;335562769&quot;:0}\"><\/p><ul><li>Consultation on selecting the right sterilization process<\/li><li>Support in defining and executing sterilization validation<\/li><li>Regulatory compliance guidance for global approval<\/li><\/ul><p><\/p><p><\/p><p><\/p><p><\/p>\n<h2>Comprehensive solutions for medical device validation.<\/h2>\n<p>We ensure that your medical device validation process is efficient, compliant, and tailored to your product needs.<\/p> <p>Tell us what you need\u2014we\u2019re ready to help you move forward.<\/p>","_links":{"self":[{"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/pages\/31166","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/users\/58"}],"replies":[{"embeddable":true,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/comments?post=31166"}],"version-history":[{"count":48,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/pages\/31166\/revisions"}],"predecessor-version":[{"id":55735,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/pages\/31166\/revisions\/55735"}],"up":[{"embeddable":true,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/pages\/32448"}],"wp:attachment":[{"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/media?parent=31166"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/categories?post=31166"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/elosmedtech.com\/de\/wp-json\/wp\/v2\/tags?post=31166"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}