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.

This is primarily a one-person practice. When you work with me, you work with me directly. Every strategy, every document, every response to a Notified Body carries my personal expertise and accountability. For larger projects, I may bring in carefully selected independent professionals when additional capacity is genuinely needed, and I will always discuss that openly before it happens. I also collaborate with trusted specialists in areas outside my core scope, such as software regulatory pathways, full QMS setup from scratch, or stand-alone risk management system builds.

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.