Team

CARLOS GALAMBA, MSc

FOUNDER & HEAD OF QA/RA & IVD

Carlos Galamba is an accomplished leader in diagnostics, known for his impressive track record of success. As the founder of MDx CRO, Carlos has extensive experience in consultancy and regulatory roles, making him a leading expert in the field. He has also served as Vice President for Diagnostics at RQM+, the world’s largest medtech consultancy, and is an independent advisor to the EU Commission.

Carlos spent several years of his career at BSI, where he developed a global network of relationships with top EU Notified Bodies. As the first in-house clinician for IVDs at BSI, he led the implementation of the BSI clinical oversight process, providing hundreds of CE marking recommendations for IVDs and supporting IVDR Notified Body designations.

Before joining BSI, Carlos held positions at the UK competent authority, the MHRA, and worked as a lead scientist in the UK National Health System, specializing in transfusion and transplantation medicine. He played a crucial role in hospital and laboratory preparedness for emerging infectious diseases, including the Ebola crisis in 2014. Carlos’s expertise in high-risk Class C and D IVDs and his ability to navigate complex regulatory environments have earned him recognition as one of the world’s top 25 influential figures in the medtech industry.

DAVID TOMÉ, MSc.

FOUNDER & HEAD OF CLINICAL OPERATIONS & MEDICAL WRITING

David is in charge of the Project Operations.

David Tomé completed his MSc in Environmental Biology and has more than 15 years of experience working internationally with the MedTech Industry, Research and Development departments, scientific data support initiatives, communication with evidence-based medicine, and healthcare stakeholders.

David has spent his career managing operations supported by science, notably in the clinical and regulatory sectors with Medical Devices and In-Vitro Diagnostic Devices. He has built a methodical and ethical approach to organizing regulatory, clinical, and technical teams in a win-win partnership with manufacturers, key purchasers, principal investigators, engineers, clinical sites, opinion leaders, and marketers.

During this time, David has worked on more than 100 MedTech product initiatives that have met and, in some cases, exceeded their initial goals. He is currently a MedTech guest speaker in academic settings and healthcare business institutions.

ANDRÉ MOREIRA, MSc.

QUALITY AND REGULATORY CONSULTANT

André is a Quality and Regulatory Expert for medical devices, IVDs, and biotech projects.

He has a background in Biomedical Engineering and a specialization in microbiology, quality, and clinical engineering. He completed an MSc in Health Care Economics and Management, enhancing his technical skills for strategy and operational management, data analysis and statistics in the healthcare sector. André has more than 7 years of experience in the areas of quality management, regulatory affairs , continuous improvement, as well as research, design & development across the MedTech industry.

He was responsible for the implementation and maintenance of quality management systems at manufacturers and other economic operators and for the creation and updating of medical device files, including clinical evaluation and post-market surveillance processes, for several medical device categories, including suction bags, intravenous infusion and blood transfusion sets, bloodlines, fistula needles, irrigation sets, swabs, orthodontic aligners and implantable devices for dental medicine.

André is also a qualified auditor for quality management systems based on ISO 9001 and 13485 and collaborates with external certification companies.

HUGO LEIS, PhD.

QUALITY AND REGULATORY CONSULTANT

Dr. Hugo Leis is a Clinical Quality and MedTech Expert for MedTech-IVD projects.

Hugo provides clinical quality assurance and clinical evaluations for medical technology and in vitro diagnostics (MedTech-IVD) development projects.

He is a veterinarian with a doctorate in molecular biology and genetics. At prestigious research institutions (CSIC, IVIA, CIEMAT, CIPF), and manufacturers, he has collaborated on basic and clinical research projects involving multidisciplinary teams studying uncommon illnesses and genetic diagnostics. He has extensive experience in the fields of analytical method development, the management of diagnostic laboratories and IVD manufacturers, and the facilitation of the idea-to-market phase of a wide range of breakthrough innovations, where he has taken the helm in terms of design, development, and regulatory operations.

Through his advanced studies in regulatory and quality management, he has gained a holistic perspective on the biotechnology process and ecosystem, including the use of software as a medical device. Furthermore, he has substantial expertise in conducting both internal and external audits for Notified Bodies and Accreditation Bodies.

Hugo is also a Guest Speaker in the academic field and in healthcare institutions.

YAIZA BENITO, MSc.

CLINICAL AND REGULATORY CONSULTANT

Yaiza is a Clinical Research and Regulatory Expert for MedTech-IVD projects.

She is a Biomedical Engineer specializing in bioengineering, software, gynecology, and clinical research affairs. Yaiza has acquired knowledge about biomechanics, clinical data analysis, and management and policy aspects of technology in healthcare in international contexts. Yaiza has completed an MSc in Technological Innovation in Health, boosting her technical skills with a comprehensive vision of the dynamic MedTech industry and startup ecosystem.

Yaiza has been part of different national and European projects related to a broad spectrum of biomedical products, including medical software, exoskeletons, remote monitoring implantable sensors, and high-risk medical devices.

Yaiza brings the MedTech start-up manufacturer and the hospital environment experience where she has worked as CRA and the adaptability to multidisciplinary teams and tasks acquired at scientific centers (CSIC), where she has collaborated as a researcher on neurorehabilitation.

CATARINA PRAGANA, MSc.

CLINICAL AND REGULATORY ASSOCIATE

Catarina is a dedicated Therapeutic Radiographer and Clinical Research Professional with 17 years of experience. Her work spans across research centers, hospitals, Clinical Research Organizations, and MedTech companies, underscoring her exceptional adaptability.

Throughout her career, she has been instrumental in various national and European projects, leveraging her extensive clinical research experience. Catarina has not only supported cancer patients through their treatment journey but also ensured compliance with Good Clinical Practice in Clinical Trials, contributing to Risk Management and Patient Safety Teams.

With a keen focus on regulations, she has managed clinical trials in line with ICH/GCP guidelines, ISO 14155, and EU MDR 2017/745, and has served as an internal auditor for ISO 9001:2015 certification and Joint Commission accreditation.

Beyond her technical capabilities, Catarina is a steadfast professional, always ready for new challenges. Following her Executive Master’s in health services management, she is currently broadening her business acumen with a Master’s in Business Administration, reflecting her dedication to continuous learning and growth.

HUIWEN XU, PhD.

CLINICAL AND REGULATORY ASSOCIATE

Dr Huiwen Xu is a Clinical and Regulatory Expert for MedTech-IVD projects.

She has a doctorate in biomedicine, specializing in medical devices and microbiota data analysis. She has collaborated on projects related to the effect of different variables such as cold, meal, and exercise on human metabolism, measuring with DXA (dual-energy x-ray absorptiometry), indirect calorimetric, and temperature sensors. In addition, she has experience performing  proof-of-concept, preclinical and clinical studies with medical device prototypes.

Furthermore, she has got experience working with international groups Magdeburg (Germany) and Granada (Spain), where she has acquired knowledge about the extraction and analysis of human microbiota.

Huiwen is also a university guest speaker in biochemistry at the University of Granada.

DIEGO RODRÍGUEZ MUÑOZ, PhD.

CLINICAL AND REGULATORY ASSOCIATE

Dr. Diego Rodríguez is a highly skilled Clinical and Regulatory Associate with expertise in medical device, IVD and biotech projects.

He holds a doctorate in Biomolecular Science, with a focus on immunology and infectious diseases. He has extensive experience collaborating on medtech projects related to various diseases, such as Covid-19 and Myelodysplastic Syndromes, and is also an expert on other diseases with global impact, such as malaria.

He has a proven track record in managing research projects in biomedicine, having worked with multiple public health institutions and hospitals.

Additionally, he has experience in testing novel, pre-clinical drugs for infectious diseases.

MARIA TRINIDAD SORIA FLORIDO, PhD

CLINICAL AND REGULATORY ASSOCIATE

Dr. María Soria Florido brings with her several years of experience working in preclinical and clinical studies. María holds a doctorate in Nutrition and Cardiovascular Disease, with her research deeply focused on the implementation of new models for cardiovascular risk prediction.

She has also worked on the study and identification of key molecular biomarkers in the development of respiratory diseases. Last, she has spent several months working on the study of cancer and its relationship with human eating habits.

We believe that her experience in data analysis, biomarker identification and in handling complex data using R and Stata will further enhance our diagnostic capabilities.

She has worked extensively in high-profile institutions including the University of Barcelona, Hospital del Mar Biomedical Research Institute and the Andalusian School of Public Health in Spain; University College London in UK; Lund University in Sweden;  and the National Health Institutes in the US.

Fluent in both English and Spanish, María adds a global perspective to our team.

MARKETA SVOBODOVA, PhD

IVD CLINICAL AND REGULATORY ASSOCIATE

Dr. Marketa Svobodova is a versatile professional specializing in medical devices and in vitro diagnostics (IVD). With extensive expertise in IVD development she brings a wealth of knowledge to MDx as a consultant specializing in clinical studies and regulatory affairs. Born in the Czech Republic, Marketa’s academic journey encompasses a degree in Biology, with a special focus on Anthropology and Human Genetics, followed by a Ph.D. in Chemical Engineering. This robust academic foundation paved the way for a remarkable career characterized by innovation and scientific rigor.

With over a decade of experience, she has been instrumental in developing a wide spectrum of in vitro diagnostic devices. Her portfolio ranges from compact antigen rapid tests to intricate devices designed to detect diverse cancer biomarkers, infectious diseases, food allergens, and toxins. Her expertise spans cutting-edge technologies like Next-Generation Sequencing (NGS) and encompasses a comprehensive knowledge of molecular biology and analytical techniques.

Demonstrating an unwavering commitment to professional growth, Marketa has recently embarked on a Master’s program in Pharmaceutical Industry and Regulatory Affairs. Her diverse experiences and commitment to excellence make her a valuable asset to MDx CRO, where she continues to shape the future of diagnostic technologies and regulatory compliance.