Helena Olbertova, Ph.D.
IVDR Regulatory & Clinical Affairs Professional | Contract, Interim & Advisory Roles
Helping IVD Manufacturers Navigate IVDR With Confidence
I support IVD manufacturers, startups, and health institutions in achieving regulatory compliance and smooth EU market access under IVDR 2017/746. With a strong scientific background (Ph.D. in oncology) and extensive hands-on regulatory experience, I provide strategic guidance, technical expertise, and interim hands-on support to ensure your products reach patients safely and efficiently.
What I Offer
Contract & Interim Roles
- Stepping into regulatory and clinical affairs functions during transitions, peak workloads, or key projects.
- Leading submissions, audits, and performance evaluation activities.
- Training and mentoring internal teams.
Advisory & Project Support
- Strategic consulting for SMEs and startups developing new IVDs or managing legacy portfolios.
- Customized compliance roadmaps and streamlined documentation frameworks.
Technical & Clinical Documentation
- Performance evaluation plans and reports
- Scientific validity reports
- Clinical evidence and monitoring plans
- Risk management files and GSPR checklists
- IVDR technical documentation and templates
Global Market Access
- Support for international registrations of CE-IVD devices beyond Europe.
Specialized Product Strategy
- Positioning and claim development for RUO and GLU products
- Boundary guidance to clarify IVDR applicability
Proven Track Record
- 45+ IVD products through IVDR certification across all device classes (A–D).
- 400+ legacy devices managed to ensure uninterrupted EU market presence.
- Audit readiness, corrective action implementation, and notified body interactions.
- Automation and AI-based approaches to streamline documentation and compliance.
Testimonials
“Helena’s expertise in regulatory strategy and compliance was invaluable. She developed clear, practical IVDR implementation strategies, created efficient templates, and supported the entire process from submission strategies to successful audits.”
Head of QA/QC Department, Medium size manufacturer
“Thank you for the consultation. It was incredibly valuable and we gained many important insights. We look forward to future collaboration.”
Client Feedback
from Kick-Off Meeting
“Thank you for the consultation. Within 60 minutes we received answers to our key questions on IVDR certification, including clear initial instructions. This allows us to plan our performance evaluation effectively. We appreciate the straightforward communication, practical tips, and the materials you shared.”
Startup stakeholders
“The pre-filled checklist has already streamlined my work. Thank you for your prompt and precise support.”
Regulatory Affairs Professional
About Me
I am Helena Olbertova, Ph.D., a Regulatory and Clinical Affairs professional specializing in in vitro diagnostic medical devices. My career bridges academic research, diagnostics manufacturing, and regulatory compliance across Europe and international markets.
I combine strategic thinking with hands-on execution, simplifying IVDR complexity so companies can focus on innovation. Known for a fast-learning, pragmatic, solution-oriented style, I set clear priorities and drive delivery under pressure. Based in the Czech Republic, I work across Europe and international markets.
Let’s Connect
If you are looking for a reliable partner to strengthen your regulatory or clinical affairs capacity, let’s discuss how I can support your project or team.
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