Medical Device & IVD Consultants

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 Tomé 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.

NICHOLAS WILSON, PhD

PRINCIPAL CONSULTANT (IVD)

Born in New Zealand, Nicholas is an experienced medical scientist with almost two decades of involvement working in a wide range of activities among various fields of medicine in both hospital and university settings. He has had sucessful periods working in Australia (Institute of Bone and Joint Research: University of Sydney), Spain (Amaris Consulting: Barcelona), UAE (Mafraq Hospital: Abu Dhabi), Switzerland (Centre on Aging and Mobility: University of Zurich), the UK (Centre for Surgical Research: University of Bristol) and Spain (RQM+: Barcelona).

Nicholas brings a wealth of knowledge to MDx, with a wide range of skills and knowledge such as: quality and regulatory consultancy for IVD and MD companies, rheumatology and immunology, musculoskeletal diseases, pharmacology, health- and pharmaco-economics, clinical study management and methodology, surgical innovation and geriatrics.

Prior to his tenure at MDx, Nicholas served as the technical lead at RQM+, the largest medtech consultancy globally. In this role, he collaborated with major multinational IVD corporations, guiding them through the intricate regulatory landscape and enabling them to successfully overcome challenges in launching their products in the market.

KARA MCNAIR, PhD

PRINCIPAL CONSULTANT

Dr Kara McNair is an experienced regulatory consultant with over 25 years’ experience in the in vitro diagnostic (IVD) and medical device (MD) arenas, as well as significant experience working within the pharmaceutical industry. Her knowledge spans numerous therapeutic areas including neurology, pain, oncology, rheumatology, and autoimmune diseases.

Kara started her career working for Pfizer and Novartis, before studying towards a PhD in Neuroscience. Following a distinguished career in academia, she re-joined industry, working as part of the clinical team for the leading silicone implant medical device company, GC Aesthetics. After being approached by the global MedTech consultancy, RQM+, Kara joined their team as a technical lead, managing large scale projects for some of the largest IVD manufacturers across the globe. Her success in this role led to her becoming the Practice Manager at RQM+, responsible for the oversight and development of over 70 clinical and post market regulatory consultants.

Kara continues in her role as a Principal Regulatory Scientist with MDx, bringing a wealth of both knowledge, and experience to the company.

ANDRÉ MOREIRA, MSc.

QUALITY AND REGULATORY MANAGER

André Moreira 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 MANAGER

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, serving as an IVD Consultant.

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 MANAGER

Yaiza Benito 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.

MARKETA SVOBODOVA, PhD

IVD CLINICAL AND REGULATORY ASSOCIATE

Dr. Marketa Svobodova is a versatile professional specializing in medical devices and in vitro diagnostics (IVD), serving as an IVD Consultant. 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.

VICTORIA BACHILLER, MSc

Regulatory & Clinical Manager

Victoria Bachiller is an efficient and accurate professional with experience in Regulatory, Clinical and Quality of medical devices.

Victoria is a multidisciplinary professional always craving for knowledge. She completed a Pharmacy degree and 2 MSc in Biotechnology for Health and Sustainability and Biotechnology for Assisted Reproductive Technology (ART). Along her professional journey she had the chance to know inner management of multiple clinical environments such as hospitals, clinical and embryology laboratories and points of care.

She has also played an important role in science, by collaborating with the Liver and Digestive Diseases Networking Biomedical Research Centre. Her expertise includes playing an essential role in the publication of scientific projects and preclinical studies in relation to investigating components of the innate immune system that were known to trigger hepatocellular carcinoma.

Before joining MDx CRO, Victoria helped manufacturers of medical devices and IVDs as an RA/QA consultant. By combining her knowledge in histopathological cancer markers, ART products, intraperitoneal cancer therapy and lots of other products she was crucial to maintain and put different devices in the right regulatory context of the European market. Moreover, as a responsible, organized and perceptive person she could help manage and lead teams to learn, prosper and achieve common objectives

GRACE CHIA, PhD

SENIOR CLINICAL AND REGULATORY ASSOCIATE

Dr. Grace Chia is a skilled medical writer in the MedTech industry with experience in both EU MDR and EU IVDR projects. She holds a doctorate in Molecular Medicine, specialising in carcinogenesis, immunology, gene expression and protein profiling.

In addition to being a regulatory writer, Grace is an experienced medical communication and scientific communication writer, translating research into daily clinical practice as well as for the general public. Besides, she has been working closely with hospitals and surgeons by coordinating and supporting clinical trials associated with diabetic foot ulcer and contact dermatitis.

Grace has delivered and collaborated in various MedTech projects while working in a large US consulting firm. These projects included various classes of medical devices (such as urine meter, surgical gloves, vision care products and vascular disease devices, among others) and IVD devices (particularly in the field of haematology, cancer diagnostics and tumour markers).

Apart from authoring reports for MDR and IVDR, Grace is also the technical reviewer of such reports. Additionally, she is one of the external reviewers for a manufacturer of spinal implants.

CATARINA PRAGANA, MSc.

CLINICAL AND REGULATORY ASSOCIATE

Catarina Pragana 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.

INES EULALIO, BSc, MSc

IVD REGULATORY ASSOCIATE

Inês Eulálio is a passionate life sciences enthusiast, skilled in molecular biology laboratory techniques applied to human diagnostics and food analysis. Always eager to learn and develop new skills, bringing together the bench work with quality management and regulatory affairs. Inês holds a bachelor’s degree in biomedical sciences and a master’s degree in molecular biotechnology.

Inês has developed several molecular biology testing methodologies in multiple environments. Her skills range from R&D experience in clinical setting, under ISO 15189:2012, and IVD tests development, under ISO 13485. Inês took a detour on the food authenticity and safety world, in R&D and operational management at laboratories working under ISO 17025:2018. She has worked in multiple European projects as well as the implementation and maintenance of quality management systems at laboratories.

CLAUDIA LOUREIRO, PhD

IVD REGULATORY ASSOCIATE

Beginning her journey with a Master’s degree in Biochemistry, Cláudia Loureiro has since carved a niche for herself in the world of science. Her pursuit of knowledge continued with a Ph.D. in Biology, where she focused her research on deciphering complex signaling pathways and their implications in hypertension and cystic fibrosis disease.

With a rich background that spans over a decade in a laboratory environment, Cláudia has been at the forefront of molecular and cell biology studies. Her work in the design and development within the molecular diagnostics field is both extensive and impactful. Her portfolio showcases a range of projects from real-time PCR tests to antigen rapid tests, addressing critical issues in human health, food authenticity and safety, and animal health.

Cláudia’s dedication to research and development has seen her managing projects in clinical settings and the development of IVD tests, all while adhering to the high standards of ISO 13485 and IVDR. Her role extends beyond research, encompassing operational management in laboratories, where her expertise continues to drive innovation and excellence.

CALLUM PICKETT, MSc

CLINICAL AND REGULATORY ASSOCIATE

Callum Pickett is a highly competent Clinical Research and Regulatory Associate, bringing a wealth of multidisciplinary skills from the In Vitro Diagnostics (IVD) sector.

Born and residing in the UK, Callum graduated with a First Class Master’s degree in Biochemistry from the University of Southampton. Following his time at university, he completed a summer internship as a continuation of his Master´s, focussed on developing a novel viral amplification technique and a CRISPR viral detection test.

Callum began his career in the R&D team of an IVD manufacturer, where he gained invaluable experience in product development and analytical performance. With the introduction of the IVDR 2017/746, he became a subject matter expert (SME) in Performance Evaluation, Clinical Performance, and ISO 20916 after transitioning into Clinical Affairs.

Since then, Callum has amassed extensive experience in developing and managing Clinical Performance Studies, Performance Evaluation, Scientific Validity, and Post-Market Activities to generate the clinical evidence necessary for the CE marking of IVDs.