{"id":635,"date":"2024-05-21T12:18:06","date_gmt":"2024-05-21T10:18:06","guid":{"rendered":"https:\/\/lenus.site\/scbest\/dispositivi-medici\/"},"modified":"2025-01-08T11:04:23","modified_gmt":"2025-01-08T10:04:23","slug":"biomedical-devices","status":"publish","type":"page","link":"https:\/\/sc-best.eu\/en\/biomedical-devices\/","title":{"rendered":"Biomedical Devices"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_wp_custommenu nav_menu=&#8221;4&#8243; el_class=&#8221;menu_servizi_tossicologici menu_servizi_tossicologici_magico&#8221; title=&#8221;X&#8221;][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJ0cmlnZ2VyX21hZ2ljbyUyMiUzRUV4cGxvcmUlMjBvdGhlciUyMHNlcnZpY2VzJTNDJTJGZGl2JTNF[\/vc_raw_html][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb250YWluZXJfdHJpZ2dlcl9tb2JpbGUlMjIlM0UlMEElMjAlMjAlM0NkaXYlMjBjbGFzcyUzRCUyMnRyaWdnZXJfbWFnaWNvX21vYmlsZSUyMiUzRSUwQSUyMCUyMCUyMCUyMEV4cGxvcmUlMjBvdGhlciUyMHNlcnZpY2VzJTBBJTIwJTIwJTNDJTJGZGl2JTNFJTBBJTNDJTJGZGl2JTNF[\/vc_raw_html][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text]As a team of expert toxicologists, we deliver proper pre-clinical evaluation of the safety of your final medical device according to international standards. During the development phase we provide guidance to ensure the biocompatibility of your device. Our extensive knowledge of different standards and guidelines, including but not limiting to the ISO 10993 series and ISO 14971, enables us to support your submissions not only in Europe according to MDR but also in other Countries, such as the United States in line with FDA requirements.<br \/>\nAmong the services, we can provide you:[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1719851308027{background-color: #f7f7f7 !important;}&#8221;][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Biological evaluation according to <strong>ISO 10993-1<\/strong>, based on the individual constituents and intended use (duration and nature of body contact). Assessment of other factors such as manufacturing including sterilization and packaging to mitigate the biological risk<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Preparation of <strong>Biological Evaluation Plan (BEP)<\/strong>: identification of tests that are required to assess the biocompatibility of the device; preparation of scientific rationale to address and waive some tests indicated by the standards<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>Biological Evaluation Report (BER)<\/strong>: preparation of a document reporting all the results obtained from the tests (chemical, biocompatibility), and scientific information from open literature to support the safety of the device<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>Toxicological Risk Assessment of medical device constituents<\/strong> according to ISO 10993-17:2023, ISO 18562 series, and related standards<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Based on the new MDR requirements, preparation of an expert opinion to assess any pharmacological action of the ingredients of the substance-based devices<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>As requested by MDR, identification of CMR and ED present in the device or absence declaration<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Components and material assessment with information from open literature<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Study monitoring and assistance during the testing phase and contact with the testing facilities<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Study monitoring and assistance in preparation of BEP and BER in line with FDA requirements, fill out the e-star model<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Identification of substances that could become classified as CMR and ED in the near future<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>Gap-analysis<\/strong> to understand the tests\/analysis that might be missing or need to be implemented (comparing old and latest versions of ISO standards), to be compliant with the MDR requirements<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Risk assessment of devices containing <strong>nanoparticles<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Regulatory consultancy also available, via third party<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1716367939388{background-image: url(https:\/\/sc-best.eu\/wp-content\/uploads\/2024\/05\/SC-BEST_template_servizi-tox.jpg?id=215) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column][vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;2\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_column_text]<\/p>\n<h2><span style=\"color: #663300;\">BIOTECHNOLOGICAL<br \/>\nSKILLS<\/span><\/h2>\n<p><span style=\"color: #663300;\">We are experts in optimizing biological processes and in creating innovative, customized, and cutting-edge products<\/span>[\/vc_column_text][vc_btn title=&#8221;Find out more&#8221; style=&#8221;flat&#8221; color=&#8221;warning&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-chevron-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fsc-best.eu%2Fen%2Fbiotechnological-skills%2F|title:Biotechnological%20skills&#8221;][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;100px&#8221;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_wp_custommenu nav_menu=&#8221;4&#8243; el_class=&#8221;menu_servizi_tossicologici menu_servizi_tossicologici_magico&#8221; title=&#8221;X&#8221;][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJ0cmlnZ2VyX21hZ2ljbyUyMiUzRUV4cGxvcmUlMjBvdGhlciUyMHNlcnZpY2VzJTNDJTJGZGl2JTNF[\/vc_raw_html][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb250YWluZXJfdHJpZ2dlcl9tb2JpbGUlMjIlM0UlMEElMjAlMjAlM0NkaXYlMjBjbGFzcyUzRCUyMnRyaWdnZXJfbWFnaWNvX21vYmlsZSUyMiUzRSUwQSUyMCUyMCUyMCUyMEV4cGxvcmUlMjBvdGhlciUyMHNlcnZpY2VzJTBBJTIwJTIwJTNDJTJGZGl2JTNFJTBBJTNDJTJGZGl2JTNF[\/vc_raw_html][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text]As a team of expert toxicologists, we deliver proper pre-clinical evaluation of the safety of your final medical device according to international standards. During the development phase we provide guidance to ensure the biocompatibility of your device. Our extensive knowledge of different standards and guidelines, including but not limiting [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":580,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-635","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Biomedical Devices - S&amp;C BEST<\/title>\n<meta name=\"description\" content=\"S&amp;C BEST provides a correct pre-clinical safety assessment of your medical device according to international standards.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sc-best.eu\/dispositivi-medici\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biomedical Devices - 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