{"id":1546,"date":"2026-09-14T21:15:05","date_gmt":"2026-09-14T19:15:05","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1546"},"modified":"2026-09-14T21:15:27","modified_gmt":"2026-09-14T19:15:27","slug":"services","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/services\/","title":{"rendered":"Slu\u017eby"},"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=\"services-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\">Slu\u017eby<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Co pro v\u00e1s mohu ud\u011blat<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">IVDR is complex and unforgiving. Whether you are launching a new IVD, transitioning a legacy portfolio, or stuck in a Notified Body review cycle, I work hands-on rather than handing you a report and leaving. I bring proven documentation frameworks and practical automation that fits the tools you already use.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I work primarily with IVD manufacturers of every size, with startups and spin-offs building their first device, and with clinical laboratories operating within the European regulatory framework or approaching it seriously as a priority.<\/p>\n<\/div>\n\n\n\n<div id=\"core-services\" 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<h3 class=\"wp-block-heading\">Projekty certifikace IVDR<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Hlavn\u00ed slu\u017eba.<\/strong> The full certification journey for new IVD products and legacy device transitions, from the initial regulatory strategy through Notified Body submission and all the steps that follow once the certificate is issued.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Anal\u00fdza ur\u010den\u00e9ho \u00fa\u010delu a klasifikace<\/li>\n\n\n\n<li>Regula\u010dn\u00ed strategie a \u0159\u00edzen\u00ed projektu<\/li>\n\n\n\n<li>Technical documentation core document and the structure of the full dossier, so the submission is complete and navigable<\/li>\n\n\n\n<li>Vytv\u00e1\u0159en\u00ed technick\u00e9 dokumentace (PEP, PER, SVR, GSPR) a podp\u016frn\u00fdch \u0161ablon<\/li>\n\n\n\n<li>Strategie odevzd\u00e1v\u00e1n\u00ed dokumentace, p\u0159\u00edprava a spr\u00e1va zp\u011btn\u00e9 vazby ozn\u00e1men\u00e9mu subjektu<\/li>\n\n\n\n<li>P\u0159\u00edprava a vyd\u00e1v\u00e1n\u00ed prohl\u00e1\u0161en\u00ed o shod\u011b EU (DoC)<\/li>\n\n\n\n<li>Kontrola marketingov\u00fdch materi\u00e1l\u016f, zna\u010den\u00ed a informac\u00ed na webov\u00fdch str\u00e1nk\u00e1ch z hlediska souladu s p\u0159edpisy<\/li>\n\n\n\n<li>Registrace v n\u00e1rodn\u00edch datab\u00e1z\u00edch a EUDAMEDu<\/li>\n\n\n\n<li>Zaji\u0161t\u011bn\u00ed zah\u00e1jen\u00ed sledov\u00e1n\u00ed po uveden\u00ed na trh a pln\u011bn\u00ed pl\u00e1n\u016f PMPF od prvn\u00edho dne<\/li>\n\n\n\n<li>Spr\u00e1va portfolia star\u0161\u00edch prost\u0159edk\u016f (legacy devices) podle IVDR<\/li>\n<\/ul>\n\n\n\n<p class=\"has-text-color has-small-font-size wp-block-paragraph\" style=\"color:#1A6B5A\">Looking for a self-paced introduction first? See my <a href=\"https:\/\/helenaolbertova.com\/cs\/training\/\">online workshops and courses<\/a>.<\/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<h3 class=\"wp-block-heading\">Notified Body Selection<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Choosing the wrong Notified Body can cost you a year. Fewer than twenty are designated for IVDR across the whole of Europe, their designation scopes differ, and their capacity is finite. The quality of your first contact decides whether you get a slot or a waiting list.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Shortlisting bodies actually designated for your device classes, codes, and conformity route<\/li>\n\n\n\n<li>Requesting and comparing quotations from several bodies, on timeline as well as price<\/li>\n\n\n\n<li>Structuring how products are distributed across certificates, which materially changes the cost<\/li>\n\n\n\n<li>Preparing and lodging the application, and handling the exchange until it is accepted<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">How products are grouped across certificates is a decision worth making deliberately rather than accepting the first proposal, and it is easier to get right before the application than afterwards.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\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<h3 class=\"wp-block-heading\">\u0158\u00edzen\u00ed zp\u011btn\u00e9 vazby pro ozn\u00e1men\u00e9 subjekty<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Uv\u00edzli jste v cyklu p\u0159ezkoum\u00e1v\u00e1n\u00ed? Zp\u011btn\u00e1 vazba od NB je \u010dasto mnohem m\u00e9n\u011b jasn\u00e1, ne\u017e byste si p\u0159\u00e1li. Pom\u016f\u017eu v\u00e1m pochopit, co ozn\u00e1men\u00fd subjekt skute\u010dn\u011b vy\u017eaduje, a p\u0159iprav\u00edm p\u0159esn\u00e9, technicky spr\u00e1vn\u00e9 odpov\u011bdi, kter\u00e9 probl\u00e9my vy\u0159e\u0161\u00ed, m\u00edsto aby posuzov\u00e1n\u00ed prodlu\u017eovaly.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Interpretace zpr\u00e1v NB o nedostatc\u00ed a objasn\u011bn\u00ed skute\u010dn\u00fdch po\u017eadavk\u016f, kter\u00e9 za t\u00edm stoj\u00ed<\/li>\n\n\n\n<li>Identifikace hlavn\u00edch p\u0159\u00ed\u010din nedostatk\u016f v technick\u00e9 dokumentaci<\/li>\n\n\n\n<li>Vypracov\u00e1n\u00ed form\u00e1ln\u00edch odpov\u011bd\u00ed a revidovan\u00fdch dokument\u016f<\/li>\n\n\n\n<li>Strategick\u00e9 zam\u011b\u0159en\u00ed odpov\u011bd\u00ed pro dosa\u017een\u00ed co nejlep\u0161\u00edho v\u00fdsledku<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">I would always rather be involved before the first submission. Catching a problem early is far cheaper than resolving it in review.<\/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<h3 class=\"wp-block-heading\">Interim Capacity When the Load Peaks<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Sometimes the problem is not competence but capacity. Your team knows exactly what needs to happen and is already fully committed to work nobody else can 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 is missing differs from company to company. Sometimes it is extra brains and hands on the documents. Sometimes it is project management to a fixed date, coordination across regulatory, R&amp;D and sales, or simply someone who knows where the older documentation actually sits. In a narrow window that layer cannot be added internally without the specialist work suffering, and hiring takes months you may not have.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I can cover a good part of it for as long as it is needed: a transition wave, a submission peak, a parental leave, or the months before a permanent hire arrives. No onboarding time, and I leave behind templates and a process your team runs on its own next time.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group card featured-card is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"service-badge-new wp-block-paragraph\">Fast Track for Larger Portfolios<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Registrace EUDAMED XML pro prost\u0159edky IVD<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Registering your IVDs in EUDAMED does not have to be a weeks-long ordeal. This is a complete service, not a file conversion: it ends when your devices are actually registered.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What the setup fee buys.<\/strong> A working session where we go through your portfolio and agree how the data will be assembled, which system each field comes from, and how your identifiers, labelling and technical documentation need to line up. My detailed Excel template. Support while your team fills it in. A review of the completed data before anything is uploaded, so errors are caught on a spreadsheet instead of inside a database record. The XML build, the upload, and confirmation that the registration went through.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>999 EUR setup fee<\/strong> covering up to 5 UDI-DIs, then 6 EUR per additional UDI-DI<\/li>\n\n\n\n<li>Rychl\u00e9 zpracov\u00e1n\u00ed od vypln\u011bn\u00e9ho Excelu po dokon\u010denou registraci v EUDAMED<\/li>\n\n\n\n<li>Po dokon\u010den\u00ed procesu m\u016f\u017eete sv\u00e9 produkty zpracov\u00e1vat p\u0159\u00edmo v EUDAMEDu.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">It applies to IVDs under the IVDR and to legacy IVDs alike. For repeat batches, once the setup is done and your data structure is agreed, the setup fee can be reduced by agreement. <strong>V sou\u010dasn\u00e9 dob\u011b k dispozici pouze pro prost\u0159edky IVD.<\/strong> A version for medical devices is in development. If that would be useful for you, get in touch and I will let you know when it is ready.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-left is-layout-flex wp-container-core-buttons-is-layout-b192c3d7 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/helenaolbertova.com\/cs\/eudamed\/\">See Both Registration Routes<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\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<h3 class=\"wp-block-heading\">Technical Documentation and Clinical Documents<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Jednotliv\u00e9 dokumenty vytvo\u0159en\u00e9 samostatn\u011b nebo jako sou\u010d\u00e1st certifika\u010dn\u00edho projektu. Pro ostatn\u00ed sou\u010d\u00e1sti technick\u00e9 dokumentace mohu p\u0159ipravit cenovou nab\u00eddku na z\u00e1klad\u011b va\u0161\u00ed konkr\u00e9tn\u00ed situace.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Technical documentation core document and a structure for the full dossier, so the submission holds together as one file rather than a folder of parts<\/li>\n\n\n\n<li>Three ways to run it: I set the strategy and your team writes, I manage the submission end to end, or I write the documents myself<\/li>\n\n\n\n<li>Pl\u00e1ny a zpr\u00e1vy o hodnocen\u00ed funk\u010dn\u00ed zp\u016fsobilosti (PEP a PER)<\/li>\n\n\n\n<li>Zpr\u00e1vy o v\u011bdeck\u00e9 platnosti<\/li>\n\n\n\n<li>Analytical and clinical performance reports<\/li>\n\n\n\n<li>Analytical and clinical performance study protocols and study reports<\/li>\n\n\n\n<li>Klinick\u00e9 d\u016fkazy a pl\u00e1ny sledov\u00e1n\u00ed po uveden\u00ed na trh<\/li>\n\n\n\n<li>GSPR checklisty<\/li>\n\n\n\n<li>P\u0159ezkum a slad\u011bn\u00ed dokumentace o \u0159\u00edzen\u00ed rizik s hodnocen\u00edm funk\u010dn\u00ed zp\u016fsobilosti, n\u00e1vodem k pou\u017eit\u00ed a aktivitami po uveden\u00ed na trh<\/li>\n<\/ul>\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<h3 class=\"wp-block-heading\">Soulad s IVDR ve va\u0161em syst\u00e9mu managementu kvality<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The deadline for IVDR QMS integration has passed. I help you check whether your existing Quality Management System truly meets what is expected under IVDR: reviewing procedures, SOPs, templates, and workflows against a structured gap analysis, then drafting the specific changes needed in each affected document.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The aim is a system that holds up in an audit and that your team can realistically maintain afterwards, not process added for its own sake. For small companies I look for the sweet spot: compliant but lean.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\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<h3 class=\"wp-block-heading\">Poradenstv\u00ed a strategick\u00e9 konzultace<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Strategick\u00e9 poradenstv\u00ed pro v\u00fdrobce, startupy a klinick\u00e9 laborato\u0159e v jak\u00e9koli f\u00e1zi v\u00fdvoje. Pom\u00e1h\u00e1m objasnit regula\u010dn\u00ed po\u017eadavky, identifikovat nedostatky a \u010dinit informovan\u00e1 rozhodnut\u00ed, ne\u017e p\u0159inesou zbyte\u010dn\u011b vysok\u00e9 n\u00e1klady.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pl\u00e1ny dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f a anal\u00fdzy nedostatk\u016f pro v\u00fdrobce IVD a mal\u00e9 a st\u0159edn\u00ed podniky<\/li>\n\n\n\n<li>In-house IVD pro klinick\u00e9 laborato\u0159e: pou\u017eitelnost IVDR a zp\u016fsoby dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f<\/li>\n\n\n\n<li>RUO and general laboratory use products: understanding IVD boundaries and available options<\/li>\n\n\n\n<li>Dal\u0161\u00ed n\u00e1zor p\u0159ed p\u0159edlo\u017een\u00edm dokument\u016f NB<\/li>\n<\/ul>\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<h3 class=\"wp-block-heading\">International Registrations<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Market access outside the EU for products that already carry a CE mark, including scope clarification, cross-department coordination, communication in English with local partners, and unblocking registrations that have stalled.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Territories worked on include European countries outside the EU, the Middle East, South America, and Asia. What I bring is the dossier and the coordination, working alongside your local distributor or registration partner who knows the national procedure.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\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<h3 class=\"wp-block-heading\">PPWR Templates for Packaging<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Regulation (EU) 2025\/40 has applied since 12 August 2026. Packaging needs its own technical documentation and its own EU declaration of conformity, separate from your device DoC, and the obligation often sits with the company whose brand is on the box rather than with the packaging supplier.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I do not consult on packaging compliance in depth. What I offer is a practical starting point: a short guide and ready-to-fill templates in eight European languages, so your team can produce the documentation without beginning from a blank page.<\/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\/ppwr\/\">See the PPWR templates<\/a><\/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<h3 class=\"wp-block-heading\">Automation Without New Software<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Templates that populate themselves from a single product data source, built inside the tools you already own. No subscription, no new platform, no vendor to onboard.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For a family of devices or a legacy portfolio, this is usually where the real time saving sits: consistent documents, fewer transcription errors, and fast updates when a requirement or an intended purpose changes. I always encourage manufacturers to use what they already have in place and keep the approach compliant but minimalist.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\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<h3 class=\"wp-block-heading\">Smluvn\u00ed a do\u010dasn\u00e9 pozice<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Need regulatory and clinical affairs capacity during a transition, peak workload, or key project? I step in as a solo interim RA\/CA specialist, leading submissions, audits, and performance evaluation activities, and training your internal staff as we go.<\/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<h3 class=\"wp-block-heading\">Training for Your Team<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Self-paced online courses, and live sessions built around your own portfolio and your own open questions. Topics delivered before include IVDR in general, IVDR for R&amp;D, IVDR for sales and marketing, distributor and importer obligations, RUO versus IVD boundaries, certifying products under Notified Body surveillance, and clinical studies for IVDR certification.<\/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\/training\/\">See all training options<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div id=\"boundaries\" class=\"wp-block-group section alt is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"section-label wp-block-paragraph\">Scope<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Where I Hand Over<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Being clear about this saves us both time.<\/p>\n\n\n\n<div class=\"wp-block-group card is-layout-flow wp-block-group-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li><strong>MDR strategy and advisory.<\/strong> I work under IVDR. I do not advise on regulatory strategy for medical devices, and for that I will point you to someone who does. Where the format and expectations for a document are already settled, I can work on the writing itself.<\/li>\n\n\n\n<li><strong>Building a QMS or a risk management system from scratch.<\/strong> I review, refine, and close gaps in what you already have. For a full build, I work with trusted independent specialists.<\/li>\n\n\n\n<li><strong>EU Authorised Representative.<\/strong> Not a service I offer.<\/li>\n\n\n\n<li><strong>Laboratory work and legal opinions.<\/strong> My background is in molecular biology, but I no longer hold a pipette and I have no laboratory of my own. Analytical and clinical performance measurements sit with your laboratory or with a specialist provider, and I will tell you when you need one. Clinical performance studies are a different matter: where you take on the sponsor role, I support the documentation, the protocol and the reporting around the study.<\/li>\n\n\n\n<li><strong>Markets.<\/strong> IVDR and the EU market are the core. For European countries outside the EU, the Middle East, South America, Asia, and other markets outside the EU, I support registration of IVDs that already carry a CE mark, not full local regulatory strategy.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Where a project runs under a grant or subsidy scheme, I can deliver the consulting work in the form the scheme requires, including a structured final project report documenting the outputs.<\/p>\n<\/div>\n\n\n\n<div id=\"services-cta\" class=\"wp-block-group section contact-section is-layout-flow wp-block-group-is-layout-flow\">\n<h2 class=\"wp-block-heading\">Not Sure Which One You Need?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">That is what the discovery call is for. Thirty minutes, free, no obligation. You will leave with a concrete next step whether or not we end up working together.<\/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\n\n\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/helenaolbertova.com\/cs\/pricing\/\">See Pricing<\/a><\/div>\n<\/div>\n<\/div>\n<\/main>","protected":false},"excerpt":{"rendered":"<p>Services What I Can Do For You IVDR is complex and unforgiving. Whether you are launching a new IVD, transitioning a legacy portfolio, or stuck in a Notified Body review cycle, I work hands-on rather than handing you a report and leaving. I bring proven documentation frameworks and practical automation that fits the tools you [&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-1546","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>Services - 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\/services\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Services - Helena Olbertova IVD Consulting\" \/>\n<meta property=\"og:description\" content=\"Services What I Can Do For You IVDR is complex and unforgiving. 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