{"id":1556,"date":"2026-09-14T21:31:42","date_gmt":"2026-09-14T19:31:42","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1556"},"modified":"2026-09-14T22:03:10","modified_gmt":"2026-09-14T20:03:10","slug":"faq","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/faq\/","title":{"rendered":"\u010cast\u00e9 ot\u00e1zky"},"content":{"rendered":"
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\u010cast\u00e9 ot\u00e1zky<\/p>\n\n\n\n

\u010casto kladen\u00e9 ot\u00e1zky<\/h1>\n\n\n\n

Real questions from IVD manufacturers, startups, and regulatory teams, answered directly. Click any question to read the full answer. If yours is not here, the form at the bottom of this page reaches me directly.<\/p>\n<\/div>\n\n\n\n

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\u0158e\u0161en\u00ed bezprost\u0159edn\u00edch probl\u00e9m\u016f<\/h3>\n\n\n\n
Zasekli jsme se v bludn\u00e9m kruhu zp\u011btn\u00e9 vazby od ozn\u00e1men\u00e9ho subjektu. M\u016f\u017eete n\u00e1m pomoci?<\/summary>\n

Yes. I act as a rescue for technical documentation and performance evaluation. I analyse the deficiency letter, identify root causes of the gaps, and prepare precise responses and revised documents. However, I always prefer to be involved before the first submission, catching issues early is far more efficient than resolving them in review.<\/p>\n<\/details>\n\n\n\n

N\u00e1\u0161 t\u00fdm v\u00fdzkumu a v\u00fdvoje je zahlcen pap\u00edrov\u00e1n\u00edm. Jak mu m\u016f\u017eete pomoci?<\/summary>\n

I can train your team on IVDR requirements, provide clear structured guidance, and take on the hands-on writing of plans and reports. This frees your scientists to focus on what they do best, developing and innovating, rather than navigating regulatory documentation.<\/p>\n<\/details>\n\n\n\n

M\u016f\u017eete kr\u00e1tce zkontrolovat na\u0161i technickou dokumentaci, ne\u017e ji ode\u0161leme ozn\u00e1men\u00e9mu subjektu?<\/summary>\n

A surface-level proofread is not very helpful at this stage. I prefer a thorough review, asking targeted questions, identifying gaps, and actually improving the file before submission. As a rule of thumb, reviewing a finished document takes a quarter to a half of the time it would take to write it, and depends on the same factors: the clarity of the inputs, how many iterations are needed, and the state of the underlying quality system.<\/p>\n<\/details>\n\n\n\n

Strategie, data a ran\u00e9 f\u00e1ze<\/h3>\n\n\n\n
Jsme v ran\u00e9 f\u00e1zi v\u00fdvoje produktu. Je p\u0159\u00edli\u0161 brzy na to, abychom zapojili konzultanta pro IVDR?<\/summary>\n

It is the best time to start. Integrating regulatory requirements into your R&D phase prevents expensive redesigns later. We can begin with shorter targeted consultations to ensure your business strategy and technical development are aligned from day one, saving significant time and cost down the line.<\/p>\n<\/details>\n\n\n\n

Jak zjist\u00edme, do jak\u00e9 rizikov\u00e9 t\u0159\u00eddy spad\u00e1 na\u0161e IVD podle na\u0159\u00edzen\u00ed IVDR?<\/summary>\n

Classification under IVDR is entirely different from the old IVDD directive. Most products are up-classified to Class B, C, or D, all under Notified Body surveillance. Together we run your intended purpose through the IVDR classification rules, which determines your entire timeline, budget, and clinical data requirements. Getting this right early is critical. If you would rather do the classification yourself, the workshop IVDR Essentials for New Product Development and IVDR Transition walks you through the Annex VIII decision tree step by step, at regulatorypath.eu<\/a>.<\/p>\n<\/details>\n\n\n\n

N\u00e1\u0161 software vyu\u017e\u00edv\u00e1 um\u011blou inteligenci k anal\u00fdze \u00fadaj\u016f o pacientech. Jedn\u00e1 se o IVD?<\/summary>\n

It could be. If your software provides diagnostic information based on data derived from a human sample, it likely falls under IVDR. Software as a Medical Device is a specialised area, particularly where it meets the EU AI Act, and it is not one I claim as my own. On projects like this I work with software specialists and cover the IVDR side myself, so both parts are handled properly and in a coordinated way.<\/p>\n<\/details>\n\n\n\n

M\u00e1me star\u0161\u00ed klinick\u00e1 data nebo data z mimoevropsk\u00fdch zem\u00ed. Mohou b\u00fdt pou\u017eita?<\/summary>\n

Ano, m\u016f\u017eete a \u010dasto byste m\u011bli. Pot\u0159eba dopl\u0148kov\u00e9 studie z\u00e1vis\u00ed na kvalit\u011b a sledovatelnosti va\u0161ich st\u00e1vaj\u00edc\u00edch \u00fadaj\u016f. IVDR vy\u017eaduje state-of-the-art klinick\u00e9 d\u016fkazy a vyu\u017eit\u00ed dob\u0159e zdokumentovan\u00fdch st\u00e1vaj\u00edc\u00edch datov\u00fdch soubor\u016f je \u010dasto kl\u00ed\u010dovou sou\u010d\u00e1st\u00ed strategie, nikoli p\u0159ek\u00e1\u017ekou.<\/p>\n<\/details>\n\n\n\n

Jak\u00fd je praktick\u00fd p\u0159\u00ednos spolupr\u00e1ce s odbornic\u00ed na regulaci, kter\u00e1 m\u00e1 doktor\u00e1t z biologie? Nejste p\u0159\u00edli\u0161 teoreticky zalo\u017een\u00e1?<\/summary>\n

My scientific background gives me a unique understanding of complex scientific projects and novel testing approaches. I have planned, developed, and presented my own research, and I use my experience in molecular biology, immunology, and good laboratory practice almost every day. The Ph.D. is not theoretical decoration, it means I understand the science behind your product deeply enough to argue it convincingly to a Notified Body.<\/p>\n<\/details>\n\n\n\n

Jak m\u016f\u017eeme spolupracovat<\/h3>\n\n\n\n
Jak za\u010d\u00edn\u00e1 a prob\u00edh\u00e1 spolupr\u00e1ce?<\/summary>\n

We begin with a discovery call to understand your exact needs, current status, and timeline. After signing an agreement, we proceed through the IVDR requirements based on your current development phase. I use a targeted question-and-answer approach to find creative, practical solutions, and I help you manage submissions, documents, and Notified Body feedback throughout the project.<\/p>\n<\/details>\n\n\n\n

M\u016f\u017eete s n\u00e1mi pracovat na na\u0161em pracovi\u0161ti?<\/summary>\n

Pracuji p\u0159edev\u0161\u00edm na d\u00e1lku prost\u0159ednictv\u00edm aplikace Teams, e-mailu a sd\u00edlen\u00fdch cloudov\u00fdch platforem, proto\u017ee to je nej\u00fa\u010dinn\u011bj\u0161\u00ed zp\u016fsob ka\u017edodenn\u00ed spolupr\u00e1ce. Pokud jde o pr\u00e1ci na m\u00edst\u011b, up\u0159ednost\u0148uji soust\u0159ed\u011bnou pr\u00e1ci na za\u010d\u00e1tku projektu: n\u011bkolik dn\u00ed a\u017e t\u00fdden, kdy spole\u010dn\u011b vytvo\u0159\u00edme z\u00e1klady, slad\u00edme se s va\u0161\u00edm intern\u00edm t\u00fdmem a stanov\u00edme jasn\u00fd sm\u011br, a pot\u00e9 pokra\u010dujeme na d\u00e1lku s p\u0159\u00edle\u017eitostn\u00fdmi n\u00e1v\u0161t\u011bvami podle pot\u0159eby. Tento rytmus funguje mnohem l\u00e9pe ne\u017e pr\u00e1ce v\u00fdhradn\u011b na d\u00e1lku nebo neust\u00e1l\u00e9 cestov\u00e1n\u00ed. S\u00eddl\u00edm v ji\u017en\u00ed Morav\u011b, co\u017e je v\u00fdhodn\u00e9 pro klienty v okol\u00ed Brna, Bratislavy a V\u00eddn\u011b. Kdy\u017e u\u017e m\u00ed\u0159\u00edm na leti\u0161t\u011b, c\u00edl cesty nen\u00ed tak d\u016fle\u017eit\u00fd. Za zaj\u00edmav\u00fdm projektem r\u00e1da cestuji kamkoli v Evrop\u011b.<\/p>\n<\/details>\n\n\n\n

Kolik \u010dasu bude n\u00e1\u0161 intern\u00ed t\u00fdm muset v\u011bnovat procesu IVDR?<\/summary>\n

Cel\u00fd proces nelze zadat extern\u011b. V\u00e1\u0161 t\u00fdm mus\u00ed poskytnout technick\u00e9 specifikace, surov\u00e1 laboratorn\u00ed data a podrobnosti o v\u00fdrob\u011b a syst\u00e9mu \u0159\u00edzen\u00ed kvality. Nicm\u00e9n\u011b v\u00fdrazn\u011b sn\u00ed\u017e\u00edm v\u00e1\u0161 intern\u00ed \u010dasov\u00fd z\u00e1vazek t\u00edm, \u017ee stanov\u00edm strategii a p\u0159iprav\u00edm dokumenty. Moji klienti \u010dasto uv\u00e1d\u011bj\u00ed, \u017ee se jim okam\u017eit\u011b ulevilo, kdy\u017e kone\u010dn\u011b v\u011bd\u011bli, kde p\u0159esn\u011b za\u010d\u00edt, co se od nich o\u010dek\u00e1v\u00e1 a kter\u00e9 nedostatky je t\u0159eba nejprve odstranit.<\/p>\n<\/details>\n\n\n\n

Vytvo\u0159\u00edte n\u00e1\u0161 syst\u00e9m \u0159\u00edzen\u00ed kvality a \u0159\u00edzen\u00ed rizik od z\u00e1klad\u016f?<\/summary>\n

Vytvo\u0159en\u00ed syst\u00e9mu \u0159\u00edzen\u00ed kvality (QMS) nebo \u0159\u00edzen\u00ed rizik od nuly nespad\u00e1 do m\u00e9 p\u0159\u00edm\u00e9 p\u016fsobnosti, ale nen\u00ed to bezv\u00fdchodn\u00e1 situace. Spolupracuji s nez\u00e1visl\u00fdmi odborn\u00edky, kte\u0159\u00ed se na tuto oblast specializuj\u00ed. Osobn\u011b prov\u00e1d\u00edm revizi a navrhuji vylep\u0161en\u00ed va\u0161eho st\u00e1vaj\u00edc\u00edho QMS a \u0159\u00edzen\u00ed rizik, abych ov\u011b\u0159ila, \u017ee pln\u011b spl\u0148uj\u00ed po\u017eadavky IVDR, a podporuj\u00ed va\u0161i technickou dokumentaci. Pokud pot\u0159ebujete vytvo\u0159it kompletn\u00ed syst\u00e9m QMS v r\u00e1mci va\u0161eho projektu IVDR, m\u016f\u017eeme se domluvit na koordinovan\u00e9m p\u0159\u00edstupu s dal\u0161\u00edmi specialisty.<\/p>\n<\/details>\n\n\n\n

Pro koho va\u0161e slu\u017eby NEJSOU ur\u010deny?<\/summary>\n

I communicate very directly and do not sugar-coat reality. My services are not for manufacturers who want to hand over IVDR entirely and remain passive. You cannot just buy a stamp, the entire company must change its internal habits and culture to be truly compliant. I am a partner in the work, not a shortcut around it.<\/p>\n<\/details>\n\n\n\n

How quickly can you start?<\/summary>\n

Sometimes immediately, sometimes not. I am one person, so it depends entirely on what you need and what is already booked. I balance my capacity carefully so every client gets the attention their project deserves. Tell me your deadline and scope on a discovery call and you will get an honest answer, including “not in time” if that is the truth.<\/p>\n<\/details>\n\n\n\n

Who owns the documents you produce?<\/summary>\n

You do. Everything I author for you is yours, in editable source format, handed over as it is produced rather than at the end of the project. There is no lock-in and nothing sits on a platform you cannot access. What stays mine is my own know-how and the original templates and methods I bring into the project, so those are not for onward distribution or resale unless we agree otherwise. Trust and professional conduct run both ways here, and they matter to me.<\/p>\n<\/details>\n\n\n\n

Trust, Data, and Scope<\/h3>\n\n\n\n
Do you sign an NDA?<\/summary>\n

Yes. I have my own NDA template, which is usually the quickest route, and I am equally happy to sign yours. Either way it makes no difference to how I handle your information: I treat every project as confidential whether an NDA is in place or not.<\/p>\n<\/details>\n\n\n\n

How do you handle our data?<\/summary>\n

Client information is not shared with third parties and does not go into random applications. I take data safety seriously and work within what your own environment and your own agreement allow. If you have specific requirements on data handling, tell me at the start and we will put them in the agreement.<\/p>\n<\/details>\n\n\n\n

Are you independent of Notified Bodies?<\/summary>\n

Yes. I work for manufacturers only. If a situation arose where that independence could be questioned, I would tell you before taking the work.<\/p>\n<\/details>\n\n\n\n

Which regulations and markets do you cover?<\/summary>\n

IVDR (EU) 2017\/746 is my core. I do not advise on regulatory strategy under MDR, though where the format and expectations for a document are already settled I can work on the writing itself. 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. I am not an EU Authorised Representative and do not offer that service.<\/p>\n<\/details>\n\n\n\n

Can you work within a grant or subsidy project?<\/summary>\n

Yes. Where a project runs under a funding scheme, I deliver the consulting work in the form the scheme requires, including a structured final project report documenting the outputs and the outcome.<\/p>\n<\/details>\n\n\n\n

Investice a dal\u0161\u00ed kroky<\/h3>\n\n\n\n
Jak dr\u017e\u00edte krok s neust\u00e1l\u00fdmi zm\u011bnami v p\u0159edpisech?<\/summary>\n

I stay continuously alert to regulatory updates and proactively share relevant insights with my regular clients, highlighting new requirements, guidance documents, or shifts in Notified Body expectations. I also bring back practical information from congresses, training sessions, and industry events. You should never be surprised by a regulatory change that I have already spotted.<\/p>\n<\/details>\n\n\n\n

M\u016f\u017eeme si va\u0161e slu\u017eby dovolit?<\/summary>\n

The prices are published, so you can answer that before you call. Consultations are 60 EUR for 30 minutes and 120 EUR for an hour. EUDAMED XML registration is 999 EUR for up to 5 UDI-DIs and 6 EUR for each one after that, and the setup fee can be reduced by agreement when you come back with a further batch. Retainers start at 99 EUR a month. Online courses start at 39 EUR, and one is free. Projects are quoted after a discovery call, and the rate on longer work is meaningfully lower than the single-consultation rate.<\/p>\n\n\n\n

My goal is to keep expert IVDR guidance genuinely accessible, including for companies working with tighter budgets. I always keep the commercial potential of your product in mind, because sustainable compliance is the goal, not compliance for its own sake.<\/p>\n<\/details>\n\n\n\n

Jak\u00e9 jsou faktura\u010dn\u00ed a platebn\u00ed podm\u00ednky?<\/summary>\n

Faktury vystavuji v eurech i v \u010desk\u00fdch korun\u00e1ch<\/strong>, you choose whichever works best for your company and location. I am a registered VAT payer in the Czech Republic (pl\u00e1tce DPH<\/em>), so Czech VAT applies where required by law. For one-off services and fixed-scope projects, payment is due in advance. For ongoing work where the monthly hours vary, invoicing at the end of the month is usually more practical, and that is what I agree with clients I already know. Payment period is 14 days. Specific terms are always confirmed in our agreement before we start.<\/p>\n<\/details>\n\n\n\n

Jak\u00e9 ot\u00e1zky bychom m\u011bli zv\u00e1\u017eit p\u0159ed prvn\u00edm kontaktem?<\/summary>\n

Before we speak, I recommend your team discusses: What happens to your market position if you do nothing? How would a 12-month delay in CE-marking impact your revenue? What is the biggest operational challenge your RA\/QA team faces right now? Are you prepared to invest meaningfully into your IVDR readiness and ongoing Notified Body surveillance? These questions will make our discovery call far more productive.<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Still Have a Question?<\/h2>\n\n\n\n

You will be talking directly to me. No sales team, no hand-offs. Book a call, write to me, or connect via LinkedIn.<\/p>\n\n\n\n

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Rezervujte si bezplatnou 30minutovou sch\u016fzku<\/a><\/div>\n\n\n\n
LinkedIn<\/a><\/div>\n<\/div>\n\n\n\n

Prefer to write? The kontaktn\u00edho formul\u00e1\u0159e<\/a> reaches me directly.<\/p>\n<\/div>\n<\/main>","protected":false},"excerpt":{"rendered":"

FAQ Frequently Asked Questions Real questions from IVD manufacturers, startups, and regulatory teams, answered directly. Click any question to read the full answer. If yours is not here, the form at the bottom of this page reaches me directly. Solving Immediate Issues Strategy, Data, and Early Stages How We Work Together Trust, Data, and Scope […]<\/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-1556","page","type-page","status-publish","hentry"],"yoast_head":"\nFAQ - 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\/faq\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ - Helena Olbertova IVD Consulting\" \/>\n<meta property=\"og:description\" content=\"FAQ Frequently Asked Questions Real questions from IVD manufacturers, startups, and regulatory teams, answered directly. 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