As the Chief Quality Officer of JO Medical Solutions, I bring over 14 years of experience in clinical practice, research, publishing, and healthcare administration. I graduated from the First Faculty of Medicine at the Medical University of Warsaw in 2010 and earned my PhD in 2016 from the Second Faculty of Medicine at the same university, with a dissertation focusing on cardiac imaging.

I have completed several international internships, including at Harvard Medical School in Boston, the German Heart Centre and Klinikum Rechts der Isaar in Munich, Universita degli Studi di Milano in Milan, and Toho Medical University in Tokyo. My academic experience primarily comes from the invasive and noninvasive cardiology, hypertension, and angiology departments at both the Central Clinical Hospital of the Ministry of Internal Affairs in Warsaw and the Central Clinical Hospital of the Medical University of Warsaw. Since 2020, I have served as the Medical Director and Head Echocardiographer at JO Medical Center.

I am a member of both the Polish and European Societies of Cardiology, and since 2019, I have held the prestigious title of Fellow of the European Association of Cardiovascular Imaging (FEACVI). Additionally, since 2021, I have held individual accreditation from the Association of Echocardiography of the Polish Cardiac Society to perform echocardiographic examinations.

I have authored over 60 articles in Polish and international journals, contributed numerous chapters to medical monographs and books, and presented extensively at major cardiology conferences worldwide. For over ten years, I have reviewed articles for highly impacted medical journals and actively participated in various clinical trials.

I have been the Chief Quality Officer at JO Medical Solutions since 2018, where my focus is on establishing and maintaining rigorous quality standards for all medical writing and documentation produced by the agency. I ensure that all materials comply with regulatory guidelines while reflecting the latest advancements in medical science.

By implementing comprehensive quality assurance protocols and conducting regular audits, I strive to enhance the accuracy, clarity, and relevance of our content. My commitment to fostering a culture of continuous improvement empowers our writers to produce high-quality medical communications that meet the needs of healthcare professionals and patients alike. I also emphasize the importance of effective communication, providing training on best practices in medical writing, and promoting interdisciplinary collaboration to ensure our outputs are both scientifically robust and easily understood.

As the CEO and Head Medical Writer at JO Medical Solutions, I bring over 15 years of experience in clinical trials, regulatory documentation, and medical device certification, underpinned by a strong foundation in cardiology and academic research. I graduated from the First Faculty of Medicine at the Medical University of Warsaw in 2008, defended my PhD in 2010, and received my habilitation in medical sciences in 2019, culminating in the title of Professor in 2024. My clinical expertise was honed at the Invasive Cardiology Clinic of the Central Clinical Hospital of the Ministry of Internal Affairs in Warsaw, with specializations in cardiology (2016) and hypertensiology (2018).

With a track record of contributions to over 80 clinical trials approved by both the EMA and FDA, my responsibilities span from drafting study protocols, investigator brochures (IB), case report forms (CRF), and informed consent forms (ICF), to compiling clinical study reports (CSR) and managing regulatory product labeling (US PI, EU SmPC) for phases I-V clinical trials, including first-in-human and bioequivalence studies. As a medical monitor, I leverage my expertise in MedDRA/IMDRF coding to participate in DSMB/IDMC committees, ensuring data integrity and safety oversight.

My educational background includes postgraduate studies in Quality Management Systems for Medical Devices at SGH Warsaw School of Economics (2023-2024), certification as a Medical Device Regulation Manager, ISO 13485 auditor, and qualifications in risk analysis (ISO 14971), biocompatibility, usability engineering, and clinical evaluation under MDR 2017/745. These credentials allow me to manage the full spectrum of regulatory and certification processes for medical devices. I have authored over 90 clinical evaluation reports, risk analyses, PMS plans, PSURs, PMCF plans/reports, and SSCPs, and I serve as a clinical expert for notified bodies, advising on device certification and regulatory compliance.

In addition to my regulatory work, I have authored over 100 manuscripts, abstracts, and presentations in peer-reviewed journals, with a cumulative Impact Factor exceeding 320 and an H-index of 17. I also provide expert translations of regulatory and scientific documents between Polish and English.

At JO Medical Solutions, my mission is to merge clinical excellence with regulatory expertise, ensuring that medical innovations not only meet the highest standards but also translate into better patient outcomes and safety