Kontakt
Let’s Talk About Your Project
You will be talking directly to me. No sales team, no hand-offs, no qualification call before the real one. Tell me where you are and what needs to happen, and you will get a straight answer, including when I am not the right person for it.
Write to Me
The more you can tell me about your device, your stage, and your deadline, the more useful my first reply will be. I answer personally, usually within two working days.
Prefer to Book a Time?
Free discovery call, 30 minutes. Your situation, your timeline, and a concrete next step. No obligation.
Paid consultation. For a specific question that needs a proper answer now, in 30, 60, 90 or 120 minute slots. Send your question in advance and I come prepared.
Practical Details
Who You Are Writing To
Helena Olbertova, Ph.D.
- Role: independent regulatory and clinical affairs consultant for IVDs
- Based in: South Moravia, Czech Republic
- Working languages: English and Czech
- Time zone: Central European Time
- LinkedIn: connect or send a message
How We Would Work
- Remote by default, via Teams, email, and shared cloud platforms
- On site when the project justifies it, ideally a focused week at the start
- Well placed for Brno, Bratislava, and Vienna, and available across Europe
- Every enquiry is treated as confidential, whether or not an NDA is signed
- Registered self-employed business in the Czech Republic, Reg. No. 09146610, VAT ID CZ687170885
Full legal information is on the Impressum page.
Worth Thinking About Before We Speak
You do not need documents for a first conversation, only questions. These four make the call considerably more useful.
- What happens to your market position if you do nothing?
- How would a twelve-month delay in CE marking affect your revenue?
- What is the biggest operational bottleneck for your RA and QA team right now?
- Are you ready to invest meaningfully in IVDR readiness and ongoing Notified Body surveillance?