I am not a theorist. I am a regulatory practitioner. With a Ph.D. in Experimental Oncology and 6+ years of frontline IVDR experience, I specialise in preparing technical files and defending them through Notified Body review rounds to secure final certification.

Before moving into regulatory work I spent years in cancer biology research at a university hospital and a research institute, planning, running and presenting my own studies. That is why clinical literature and the statistics behind it are familiar ground rather than something I outsource.

Konzultační služby poskytuji jako samostatná specialistka. Když se mnou spolupracujete, jednáte přímo se mnou. Každá strategie, každý dokument, každá odpověď oznámenému subjektu nese moji osobní zkušenost a odpovědnost. U větších projektů mohu přizvat pečlivě vybrané nezávislé odborníky, pokud je skutečně potřeba další kapacita, ale vždy o tom předem otevřeně diskutuji. Spolupracuji také s ověřenými specialisty v oblastech mimo můj hlavní obor, jako jsou regulační postupy pro software, kompletní nastavení QMS od nuly nebo budování samostatných systémů řízení rizik.

I combine scientific rigour with smart automation to handle the heavy lifting of regulatory documentation, because most of the weight in a technical file is repetition rather than thinking. Whether you need a gap analysis, a clinical performance report, or straight answers to complex questions, I deliver results rather than reports, so your business moves forward.

In 2026 I launched Regulatory Path, an online educational platform. It is the same practice in a different form: I solve IVDR problems hands-on for manufacturers, and when the same problem keeps coming back, I turn it into a course or a template so anyone can solve it themselves. Some clients start with a course and then book a consultation. Others use the courses to train their teams while I handle the certification work.

I work primarily remotely via Teams, email, and shared cloud platforms. For the right project, I am happy to travel, ideally for a focused week at the start to build the foundations together, then continue remotely with periodic visits as needed. I am not looking to be constantly travelling, but a meaningful on-site presence at key moments is something I genuinely value. I am based in South Moravia, well placed for clients in and around Brno, Bratislava, and Vienna, and reachable across Europe.

I communicate directly. I do not sugar-coat reality. What I will always give you is honesty about the effort IVDR requires, and the expertise to make that effort count.