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 EXPERT

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 EXPERT

Hugo 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 RESEARCH AND REGULATORY EXPERT

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.

HUIWEN XU, PhD.

CLINICAL RESEARCH AND REGULATORY ASSOCIATE

Huiwen 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 RESEARCH AND REGULATORY ASSOCIATE

Diego 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.

ÁNGELA FERNÁNDEZ, ML.

BUSINESS OPERATIONS ASSOCIATE

Angela is a Business Operations Associate for medical device and IVD consulting projects.

As a Lawyer, Angela gained experience in civil, commercial, international and insolvency law and has specialised in international trade.

She holds a Master´s degree in International Trade Law and is currently pursuing a Master in Digital Marketing.

At MDx, Angela supports the company’s national and international expansion strategy by assisting the leadership team with human resources, marketing, and legal compliance.

Her role is to assist the operational side of the business looking to increase efficiency and profitability whilst remaining compliant, and she is a key advocate of MDx’s unique value proposition.