Medical Device & IVD Consultants


MDx MEDICAL DEVICE AND IVD CONSULTANTS

At MDx, the provision of high-quality services in the field of medical devices and in-vitro diagnostics (IVD) is a central focus. The team consists of experienced MDR and IVDR consultants who are well-versed in guiding medical technology innovations from their conceptual stages right through to market release.

Furthermore, MDx specialists ensure that medical devices remain in compliance with quality management system (QMS) regulations, adapting to market needs over time. As recognized consultants in the transition from MDD to MDR and from IVDD to IVDR, MDx provides invaluable support to navigate regulatory shifts successfully.

In addition, the team boasts proficient medical device clinical research consultants dedicated to the effective and efficient support of clinical affairs. Through meticulous planning and rigorous execution, clinical studies are expertly managed to ensure the best possible outcomes.

MDx works harmoniously with a company’s regulatory, quality, and clinical affairs departments, offering a strategic partnership to achieve set targets while saving time and resources. Explore the benefits of collaborating with MDx and move forward in the medical device and in-vitro diagnostics industries with confidence and expertise.

 

INTERNATIONAL SUPPORT

MDx team is proficient at providing international support:

  • in 8 international languages (English, French, Italian, Czech, Catalan, Spanish, Portuguese, and Chinese).
  • for Medical Devices (MD) and Medical Device Software (MDSW/SaMD).
  • for In-Vitro Diagnostics (IVD), In-house testing (LTD), and In Vitro Diagnostics Software (IVDSW/SaIVD).
  • with MD/IVD consultants, experts, and clinical researchers that hold advanced degrees in the healthcare sciences such as PhD., Clinical Research MSc, Biomedical Engineering and Mathematics.
  • with international standards such as ISO 13485, ISO 14155, ISO 14971, ISO 20189, ISO 15189, ISO 17025, ISO 62304, and good clinical practice (GCP) and good laboratory practice (GLP) can be met with a well-trained team in medical technologies.
  • with experts in the European Regulations, EU MDR 2017/745 and EU IVDR 2017/746.

CARLOS GALAMBA, MSc picture profile

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. picture profile

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.


ANDRÉ MOREIRA, MSc. picture profile

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. picture profile

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. picture profile

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.


GRACE CHIA, PhD picture profile

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. picture profile

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. picture profile

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. picture profile

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 picture profile

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 picture profile

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.


INES EULALIO, BSc, MSc picture profile

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.





Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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