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.

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.

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.

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.

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.

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.

Ano, můžete a často byste měli. Potřeba doplňkové studie závisí na kvalitě a sledovatelnosti vašich stávajících údajů. IVDR vyžaduje state-of-the-art klinické důkazy a využití dobře zdokumentovaných stávajících datových souborů je často klíčovou součástí strategie, nikoli překážkou.

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.

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.

Pracuji především na dálku prostřednictvím aplikace Teams, e-mailu a sdílených cloudových platforem, protože to je nejúčinnější způsob každodenní spolupráce. Pokud jde o práci na místě, upřednostňuji soustředěnou práci na začátku projektu: několik dní až týden, kdy společně vytvoříme základy, sladíme se s vaším interním týmem a stanovíme jasný směr, a poté pokračujeme na dálku s příležitostnými návštěvami podle potřeby. Tento rytmus funguje mnohem lépe než práce výhradně na dálku nebo neustálé cestování. Sídlím v jižní Moravě, což je výhodné pro klienty v okolí Brna, Bratislavy a Vídně. Když už mířím na letiště, cíl cesty není tak důležitý. Za zajímavým projektem ráda cestuji kamkoli v Evropě.

Celý proces nelze zadat externě. Váš tým musí poskytnout technické specifikace, surová laboratorní data a podrobnosti o výrobě a systému řízení kvality. Nicméně výrazně snížím váš interní časový závazek tím, že stanovím strategii a připravím dokumenty. Moji klienti často uvádějí, že se jim okamžitě ulevilo, když konečně věděli, kde přesně začít, co se od nich očekává a které nedostatky je třeba nejprve odstranit.

Vytvoření systému řízení kvality (QMS) nebo řízení rizik od nuly nespadá do mé přímé působnosti, ale není to bezvýchodná situace. Spolupracuji s nezávislými odborníky, kteří se na tuto oblast specializují. Osobně provádím revizi a navrhuji vylepšení vašeho stávajícího QMS a řízení rizik, abych ověřila, že plně splňují požadavky IVDR, a podporují vaši technickou dokumentaci. Pokud potřebujete vytvořit kompletní systém QMS v rámci vašeho projektu IVDR, můžeme se domluvit na koordinovaném přístupu s dalšími specialisty.

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.

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.

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.

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.

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.

Yes. I work for manufacturers only. If a situation arose where that independence could be questioned, I would tell you before taking the work.

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.

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.

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.

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.

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.

Faktury vystavuji v eurech i v českých korunách, you choose whichever works best for your company and location. I am a registered VAT payer in the Czech Republic (plátce DPH), 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.

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.