Helena Olbertova, Ph.D.

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. That is the kind of engagement that prevents costly NB feedback cycles.

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 perfectly aligned from day one, saving significant time and cost down the line.

Classification under IVDR is entirely different from the old IVDD directives. 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.

It could be. Software as a Medical Device (MDSW) is a complex area, especially at the intersection of the EU AI Act. If your software provides diagnostic information, it likely falls under IVDR. I work with partners on similar projects, so we can cover both software-specific requirements and your IVD technical file in a coordinated way.

Yes, you can and often should. Whether a bridging study is needed depends on the quality and traceability of your existing data. IVDR requires state-of-the-art clinical evidence, and leveraging well-documented existing datasets is often a key part of the strategy rather than an obstacle.

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 organically 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.

I work primarily remotely via Teams, email, and shared cloud platforms, as this is the most efficient way to run day-to-day collaboration. For on-site work, my preference is a focused stint at the beginning of a project: a few days to a week where we build the foundations together, align with your internal team, and set a clear direction, then continue remotely with occasional visits as needed. That rhythm tends to work far better than either fully remote or constantly travelling. I am based in South Moravia, convenient for clients near Brno, Bratislava, and Vienna, and once I am heading to an airport, the destination does not much matter. I am happy to travel anywhere in Europe for the right project.

You cannot outsource the entire process. Your team must provide technical specifications, raw laboratory data, and manufacturing and QMS details. However, I significantly reduce your internal time commitment by setting the strategy and preparing documents hands-on. My clients consistently describe the immediate relief of finally knowing exactly where to start, what is expected, and which gaps to close first.

Building a QMS or risk management system from zero is outside my direct scope, but it is not a dead end. I collaborate with trusted independent professionals who specialise in exactly that. What I do personally is check and refine your existing systems to make sure they fully meet IVDR requirements and support your technical documentation. If you need a full QMS build alongside your IVDR project, we can discuss a coordinated approach.

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.

I develop smart, simple automation tools to reduce the workload for QA/RA teams. For example: my EUDAMED XML registration service turns a complex upload task into a straightforward, fast process. I also help manufacturers speed up technical documentation file creation through practical automation tools that require no additional software or subscriptions. All designed to make compliance faster without cutting corners.

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.

My goal is to keep expert IVDR guidance genuinely accessible — including for companies working with tighter budgets. I offer individual consultations for specific questions as well as fixed-fee packages for predictable budgeting. I always keep the commercial potential of your product in mind, because sustainable compliance is the goal, not compliance for its own sake.

Possibly, it depends on your IVDR submission deadline and the scope of services you need. I balance my capacity carefully so every client gets the attention their project deserves. The best way to find out is to book a free discovery call and we will establish a realistic, honest timeline together.

I invoice in both EUR and CZK — 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 project-based and one-time services, payment is typically required in advance. Long-term retainer clients receive a monthly invoice at the end of each calendar month, with a 14-day payment period. Specific terms are always confirmed in our agreement before we start.

Before we speak, I recommend your executive 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.