Helena O

I am Helena Olbertova, Ph.D., an IVD Regulatory and Clinical Affairs Consultant with a strong background in medical academic research and a proven track record of successful IVD certification projects. Based in the Czech Republic, I work with clients across Europe, and other international markets, providing reliable and professional consulting services.  With extensive experience in IVDR certification and a robust background in medical research, I am committed to providing high-quality results. By combining strategic thinking with meticulous attention to detail, I ensure your products meet rigorous certification standards, delivering modern, science-based diagnostic options to patients and hospitals worldwide.  Skilled team members with a strong life-science background and regulatory expertise are instrumental in enhancing my capacity to tackle larger projects.