{"id":1553,"date":"2026-09-14T21:23:04","date_gmt":"2026-09-14T19:23:04","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1553"},"modified":"2026-09-14T21:23:06","modified_gmt":"2026-09-14T19:23:06","slug":"case-studies","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/case-studies\/","title":{"rendered":"Case Studies"},"content":{"rendered":"<main class=\"inherit-container-width wp-block-group site-wrap has-ast-global-color-5-background-color has-background is-layout-constrained wp-block-group-is-layout-constrained\">\n<div id=\"cases-intro\" class=\"wp-block-group section page-head is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Case Studies<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">How This Works in Practice<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">These are real projects from my own practice, described without company names, product names, or locations. They are the clearest way to show what I do, how I work, and where I can help.<\/p>\n<\/div>\n\n\n\n<div id=\"case-nb-selection\" class=\"wp-block-group section is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Legacy Class C \u00b7 Six Months<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Legacy Class C Devices With No Notified Body<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">The situation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">An established IVD manufacturer, also operating an accredited clinical laboratory, with a quality system certified and maintained to ISO 13485 for years. Their previous Notified Body relationship under IVDD had ended, and that body holds no IVDR designation. A group of legacy Class C devices needed to stay on the EU market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The quality system was functional, but set up against IVDD rather than IVDR. The technical documentation was not in IVDR shape. Because the products were being innovated in parallel, historical performance data could not be reused.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The constraint<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A small company where most people hold several roles at once. Whatever we built had to be sustainable for that team after the project ended. Correct on paper was not the goal.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What I did<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ran a readiness audit across both the quality system and the technical documentation, going through the actual documents rather than working from a checklist alone<\/li>\n\n\n\n<li>Finalised the intended purpose for each device in two languages, classified each one against the Annex VIII rules with written justification, and assigned EMDN and IVDR codes<\/li>\n\n\n\n<li>Helped the client identify suitable Notified Bodies by designation scope, capacity, and expected timelines, and prepared the approach so their own team could contact three of them and compare the quotations<\/li>\n\n\n\n<li>Negotiated a different distribution of products across certificates, which brought the price down<\/li>\n\n\n\n<li>Reviewed the controlled QMS documentation against IVDR using a structured gap analysis checklist, and drafted the specific changes needed in each affected procedure<\/li>\n\n\n\n<li>Agreed the technical documentation architecture: a core document with annexes following Annex II and III, with a plan-and-report method for each area, and built the templates<\/li>\n\n\n\n<li>Set the performance evaluation strategy across all three pillars under Article 56 and Annex XIII: scientific validity, analytical performance, and clinical performance<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Result<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Application lodged and accepted, agreement on future certification signed, and a working relationship with an IVDR-designated Notified Body established. The client kept the gap analysis checklist, the revised procedures, the plan and report templates, the classification rationale, and the code assignments.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div id=\"case-legacy-volume\" class=\"wp-block-group section alt is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Legacy at Volume \u00b7 Ongoing<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A Legacy Portfolio Measured in Hundreds of Products<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">The situation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A mid-size manufacturer transitioning a large legacy portfolio to IVDR in waves. The first wave covered more than a dozen technical files, with several hundred products to follow in later waves. The first wave had a fixed Notified Body audit date that could not be moved, because the body had no other capacity that year.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">There was no realistic way to work through the products one after another. The time left per product made sequential preparation impossible, so the work had to run on automation and on several products in parallel, over the summer, alongside major registration projects outside the EU.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The constraint<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This was never a competence gap. The regulatory team knew exactly what to do and was fully committed to work nobody else could take over: documentation content, analytical and clinical studies, data, instructions for use, document control, QMS activities, postmarket and customer care.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">What was missing was extra brains and hands: advisory input on the approach, project management to a fixed date, coordination across departments, prioritisation, and knowledge of where the older documentation actually sat. Hiring was not an option, because onboarding a qualified person takes months and the deadline was weeks away.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">One part deserves naming on its own: checking the data sets. Automation can produce a large number of documents very quickly, and if the wrong information goes in, it does more harm than doing nothing. Both the templates and the data had to be tuned and verified before anything was generated at scale. All of it rested on years of working with this portfolio and knowing the company.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What I did<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Took on project management to the deadline, and coordination across regulatory, R&amp;D and sales, so the internal team could stay on the specialist work<\/li>\n\n\n\n<li>Ran the gap analysis across the legacy portfolio, including tracing where historical documentation was held<\/li>\n\n\n\n<li>Built and extended automation for document production, using structured questionnaires and auto-populating templates inside tools the company already owned, with no new software and no subscription<\/li>\n\n\n\n<li>Set up English templates and a repeatable process designed for the later, much larger waves rather than only for the package in front of us<\/li>\n\n\n\n<li>Trained the internal teams so everyone knew their own tasks, how to use the automation, and what the finished result had to look like<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Result<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The approach was validated on the first product through the Notified Body before the wave started. The automation and templates stayed with the team, which is the part that mattered, because the later waves are several times larger and are being handled largely in-house.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div id=\"case-small-team\" class=\"wp-block-group section is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Small Manufacturer<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">One Person Covering Three Departments<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">The situation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A small IVD manufacturer where a single person covers regulatory affairs, quality, and part of production support. IVDR obligations run across the whole product lifecycle and do not pause for capacity.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The constraint<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">No prospect of hiring. No budget for a quality management platform or regulatory software. Everything had to work inside the tools and the hours that already existed, or it would quietly stop being done.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What I did<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Reviewed the quality system and identified which IVDR requirements were genuinely not covered, rather than adding process for its own sake<\/li>\n\n\n\n<li>Rebuilt templates so product data entered once populates several documents automatically, with no additional software<\/li>\n\n\n\n<li>Set a realistic annual rhythm for postmarket surveillance, performance follow-up, and periodic review, so the work is spread across the year rather than stacked in front of an audit<\/li>\n\n\n\n<li>Trained the person holding all three roles, so the approach survives without me<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Result<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Compliant but minimalist, which is the only version that survives in a team of one. The documents that used to be rewritten from scratch each time now build themselves from a single data source.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div id=\"case-eudamed\" class=\"wp-block-group section alt is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">EUDAMED \u00b7 34 IVDR Devices<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">34 IVDR Devices Registered in EUDAMED in 30 Minutes<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">The situation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A manufacturer with 34 devices certified under the IVDR to register in EUDAMED, and no intention of spending weeks on manual entry.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The constraint<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Product data scattered across labelling files and internal systems, in different formats, and a registration deadline that was not moving.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What I did<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Provided a structured Excel template collecting every mandatory EUDAMED field in one place<\/li>\n\n\n\n<li>Reviewed the completed data before upload and resolved the open points with the client<\/li>\n\n\n\n<li>Converted the data into correctly formatted XML<\/li>\n\n\n\n<li>Ran the batch upload<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Result<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">34 devices registered in 30 minutes of upload time. The preparation is where the real work sits, and that is exactly the part that scales, because the same template handles the next batch.<\/p>\n\n\n\n<p class=\"has-text-color has-small-font-size wp-block-paragraph\" style=\"color:#1A6B5A\"><a href=\"https:\/\/helenaolbertova.com\/cs\/eudamed\/\">How EUDAMED registration works<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n<div id=\"case-eudamed-legacy\" class=\"wp-block-group section is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">EUDAMED \u00b7 382 Legacy Devices<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">382 Legacy IVDs That Still Earn Revenue<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Devices certified under the IVDD have to be registered in EUDAMED as well, and they follow their own identification rules. Entered one at a time, a portfolio of this size is at least sixteen full working days of a specialist doing nothing but typing, with every screen another chance to introduce an error that surfaces months later.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Result:<\/strong> prepared as structured data, reviewed once and uploaded in batches, EUDAMED stopped being a project and became an administrative step. The specialist time went back to work that actually needs a regulatory brain.<\/p>\n\n\n\n<p class=\"has-text-color has-small-font-size wp-block-paragraph\" style=\"color:#1A6B5A\"><a href=\"https:\/\/helenaolbertova.com\/cs\/eudamed\/\">How EUDAMED registration runs<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n<div id=\"case-training\" class=\"wp-block-group section alt is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Live Training \u00b7 Half a Day<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A Four-Hour Session for Production and R&amp;D<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">The situation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A manufacturer wanted its production and R&amp;D people to understand what the IVDR actually asks of them, rather than hearing it second hand from the regulatory team. Two groups with very different daily work, one session, four hours.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What I did<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Walked through how the IVDR came about, the core concepts and vocabulary, and what changed for manufacturers compared with the old directive<\/li>\n\n\n\n<li>Covered intended purpose, classification, product codes, grouping devices onto certificates for classes B and C, and sampling<\/li>\n\n\n\n<li>Explained how audits run, what a complete technical documentation file contains including performance evaluation, and what happens after the device is on the market<\/li>\n\n\n\n<li>Extended into change control and risk management, where both groups have a direct role<\/li>\n\n\n\n<li>Built the session around interactive input, so participants worked through real options themselves instead of watching slides, with specific examples prepared for each of the two groups<\/li>\n\n\n\n<li>Collected quick feedback on each topic area, covering what people already knew and what surprised them<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">The result<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Every participant received a certificate listing the content covered and carrying a unique certificate number. The company also received the collected feedback, which showed where understanding was already solid and where the next round of training should go.<\/p>\n<\/div>\n\n\n\n<div id=\"case-early-stage\" class=\"wp-block-group section is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-774bddf2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Early Stage<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Spin-Offs, Startups, and Clinical Laboratories<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Scientific and clinical laboratory teams building their first IVD, or deciding whether what they have built is an IVD at all. The work is advisory: integrating IVDR and in-house requirements into the earliest stages of development, before the design is locked.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Result:<\/strong> expensive redesign avoided by aligning R&amp;D processes with design controls and future compliance needs while changes were still cheap.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Audit Readiness<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">A First IVDR Audit<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A manufacturer facing their first IVDR audit with no prior experience of what an auditor would ask or expect. Intensive training and Q&amp;A sessions covering the documentation, the likely questions, and how to answer them without opening new ones.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Result:<\/strong> the internal team went in able to handle auditor questions and manage their compliance documentation independently afterwards.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div id=\"cases-cta\" class=\"wp-block-group section contact-section is-layout-flow wp-block-group-is-layout-flow\">\n<h2 class=\"wp-block-heading\">None of These Quite Match?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">That is normal. Book a call and tell me your situation. If I am not the right person, I will say so and point you somewhere useful.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/cal.eu\/regpathhelena\/free-discovery-call-with-helena-olbertova\" target=\"_blank\" rel=\"noreferrer noopener\">Rezervujte si bezplatnou 30minutovou sch\u016fzku<\/a><\/div>\n<\/div>\n<\/div>\n<\/main>","protected":false},"excerpt":{"rendered":"<p>Case Studies How This Works in Practice These are real projects from my own practice, described without company names, product names, or locations. They are the clearest way to show what I do, how I work, and where I can help. Legacy Class C \u00b7 Six Months Legacy Class C Devices With No Notified Body [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-1553","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Case Studies - Helena Olbertova IVD Consulting<\/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:\/\/helenaolbertova.com\/cs\/case-studies\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Case Studies - Helena Olbertova IVD Consulting\" \/>\n<meta property=\"og:description\" content=\"Case Studies How This Works in Practice These are real projects from my own practice, described without company names, product names, or locations. 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Based in the Czech Republic, I work with clients across Europe, and other international markets, providing reliable and professional consulting services. With extensive experience in IVDR certification and a robust background in medical research, I am committed to providing high-quality results. 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