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72\u002F100",[8],{"items":485,"count":54},[486,488,490,492],{"value":487,"label":487},"EMEA",{"value":489,"label":489},"APAC",{"value":491,"label":491},"Americas",{"value":493,"label":493},"Africa",[495],{"id":496,"date":497,"date_gmt":497,"guid":498,"modified":500,"modified_gmt":500,"slug":501,"status":10,"type":502,"link":503,"title":504,"content":506,"excerpt":509,"author":179,"featured_media":511,"comment_status":512,"ping_status":512,"sticky":508,"template":8,"format":513,"meta":514,"categories":515,"tags":516,"cbtw_industries":517,"cbtw_services":519,"class_list":521,"acf":531,"yoast_head":547,"yoast_head_json":548,"lang":647,"translations":648,"cbtw_post_categories":649,"header":651,"layout_builder":652,"featured_image":660,"industries":666,"services":671,"cbtw_post_author":568,"breadcrumb":676,"primary_category_name":207,"post_region":532,"featured_image_url":566,"primary_industry_name":668,"primary_service_name":673,"pll_sync_post":682,"_links":683,"_embedded":730},2556,"2024-04-09T14:55:49",{"rendered":499},"https:\u002F\u002Fstaging-admin.cbtw.tech\u002F?p=2556","2025-07-24T07:35:23","optimized-medical-devices-probe-disinfection","post","https:\u002F\u002Fstaging.cbtw.tech\u002Finsights\u002Foptimized-medical-devices-probe-disinfection",{"rendered":505},"Medical Devices optimized for Probe Disinfection",{"rendered":507,"protected":508},"\n\u003Cp>We recently had the privilege of assisting one of our clients, a global medical company dedicated to the disinfection process, allowing a \u003Cstrong>new, faster, and more robust disinfection process\u003C\u002Fstrong> in their IIb class medical devices.\u003C\u002Fp>\n\n\n\n\u003Cp>The technology behind the device is straightforward: a UV-C based technology that allows the disinfection of ultrasound probes. It has developed a system that replaces chemistry with photons and thus constitutes a technological breakthrough.\u003C\u002Fp>\n\n\n\n\u003Cp>With its technology based on UV-C radiation, the manufactured medical devices are radically different systems that use state-of-the-art technology to meet all disinfection standards. This would help develop hospital hygiene systems and simplify the lives of healthcare professionals in terms of safety, time, and responsibility.\u003C\u002Fp>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-context-of-our-client\">Context of our client\u003C\u002Fh2>\n\n\n\u003Cp>The client operates in many countries and manufactures and distributes medical devices. They approached us for a \u003Cstrong>new medical device manufacturing process\u003C\u002Fstrong> that would fully address some of their key challenges:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Be compliant with the updated standards of \u003Ca href=\"https:\u002F\u002Feur-lex.europa.eu\u002Flegal-content\u002FEN\u002FTXT\u002F?uri=CELEX%3A32017R0745\" target=\"_blank\" rel=\"noreferrer noopener\">Medical Device Regulation (EU) 2017\u002F745\u003C\u002Fa>\u003C\u002Fli>\n\n\n\n\u003Cli>Be compliant with the UK and US standards\u003C\u002Fli>\n\n\n\n\u003Cli>Challenge the sterilant and disinfectant faculties of the device\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-our-approach\">Our approach\u003C\u002Fh2>\n\n\n\u003Cp>The approach we took was very specific. As a microbiologist specialist, our consultant accompanied the company to face the challenges.\u003C\u002Fp>\n\n\n\n\u003Cp>First, the methodology used for the sterilant, potency, and simulated tests has been redesigned to meet the standards.\u003Cbr>Then, a follow-up was done on the conducted tests. We faced the scientific challenges and were able to answer \u003Ca href=\"https:\u002F\u002Fwww.aoac.org\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">AOAC\u003C\u002Fa> and FDA expectations.\u003Cbr>We also took part in the constitution of the De Novo file to manufacture beyond Europe, to make sales in the USA.\u003C\u002Fp>\n\n\n\n\u003Cp>Nevertheless, it involved all departments and resources, which made it very complex\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Management of a microbiological study with a Medical Device\u003C\u002Fli>\n\n\n\n\u003Cli>Design and drafting of microbiological study protocols with partner laboratories\u003C\u002Fli>\n\n\n\n\u003Cli>Support for specific microbiology questions from the authorities\u003C\u002Fli>\n\n\n\n\u003Cli>Writing & Proofreading reports of study results as part of a regulatory technical file (Microbiology, optics, etc.)\u003C\u002Fli>\n\n\n\n\u003Cli>Coordination of studies between partner laboratories on the project\u003C\u002Fli>\n\n\n\n\u003Cli>Animation of relations with study partners (Laboratory Managers, AOAC & FDA organization) in the context of scientific expertise\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>We helped coordinate multiple departments and resources to implement a new manufacturing process for our client’s medical devices.\u003C\u002Fp>\n\n\n\n\u003Cp>Our approach involved a \u003Cstrong>comprehensive \u003C\u002Fstrong>and \u003Cstrong>cross-functional effort\u003C\u002Fstrong> that spanned \u003Ca href=\"https:\u002F\u002Fcollaborationbetterstheworld.com\u002Fservices\u002Flife-sciences-solutions\u002F\">R&D, industrialization, quality assurance, and regulatory affairs\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-results\">Results\u003C\u002Fh2>\n\n\n\u003Cp>In conclusion, the validation of medical devices is a complex and highly regulated process, and our commitment to providing appropriate support to our clients is founded on our extensive knowledge and experience within the industry.\u003C\u002Fp>\n\n\n\n\u003Cp>With our expert guidance, we seek to alleviate the challenges associated with medical device validation and empower our clients to deliver \u003Cstrong>safe \u003C\u002Fstrong>and \u003Cstrong>effective products\u003C\u002Fstrong> to the market.\u003C\u002Fp>\n",false,{"rendered":510,"protected":508},"\u003Cp>This article delves into how their innovative solutions are setting new standards in sterilization, ensuring devices meet the highest regulatory compliance for safety and effectiveness.\u003C\u002Fp>\n",2557,"open","standard",{"_acf_changed":508,"content-type":8,"inline_featured_image":508,"footnotes":8},[43],[],[518],134,[520],135,[522,502,523,524,525,526,527,528,529,530],"post-2556","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-studies","cbtw_industries-life-sciences","cbtw_services-life-sciences-solutions",{"authors":8,"article_authors":508,"direct_external_link":8,"post_region":532,"layout_builder":533},"global",[534],{"acf_fc_layout":535,"title":190,"ui_v2":536,"short_description":537,"cbtw_related_group_filters":538,"items":508,"link":543,"hubspot_form_id":8,"mainPostId":496,"region":532},"block_insights",true,"Access related expert insights",{"cbtw_related_category_filter":539,"cbtw_related_tag_filter":540,"cbtw_related_industry_filter":541,"cbtw_related_service_filter":542},[379,192],[],[],[],{"title":544,"url":545,"target":546},"View all insights","https:\u002F\u002Fstaging.cbtw.tech\u002Finsights","_self","\u003C!-- This site is optimized with the Yoast SEO Premium plugin v25.4 (Yoast SEO v25.4) - https:\u002F\u002Fyoast.com\u002Fwordpress\u002Fplugins\u002Fseo\u002F -->\n\u003Ctitle>Optimized Medical Devices for Probe Disinfection\u003C\u002Ftitle>\n\u003Cmeta name=\"description\" content=\"CBTW's innovative UV-C technology optimizes medical devices for efficient probe disinfection, meeting global regulatory standards for safety and effectiveness.\" \u002F>\n\u003Cmeta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \u002F>\n\u003Clink rel=\"canonical\" href=\"https:\u002F\u002Fstaging.cbtw.tech\u002Finsights\u002Foptimized-medical-devices-probe-disinfection\" \u002F>\n\u003Cmeta property=\"og:locale\" content=\"en_US\" \u002F>\n\u003Cmeta property=\"og:type\" content=\"article\" \u002F>\n\u003Cmeta property=\"og:title\" content=\"Medical Devices optimized for 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