Meet the Experts Driving Regulatory & Clinical Success
Our team is what makes MDx different — a diverse network of seasoned professionals, former notified body experts, clinical researchers, QA leaders, PhD scientists and MedTech innovators working together to deliver excellence across every stage of the product lifecycle.
Clinical research leader and MedTech entrepreneur with deep expertise in medical devices, IVDs & precision medicine, with global study experience.
David Tomé
President
Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.
Carlos Galamba
CEO & Head of IVD
Strategic executive with nearly two decades of leadership experience in global talent acquisition, strategic resourcing, and business operations within the clinical research industry.
Clara Veldman
Head of Business
Senior med-tech expert & ex-Notified Body reviewer with deep experience in high-risk implants, orthopedics, dental & neurology.
Alberto Bardají de Quixano
Head of Medical Devices
Clinical Operations leader with IVD and CDx device expertise, delivering global clinical studies while establishing best practices and high performing teams.
Kirsty Macleod
Head of Clinical Research
Expert in Precision Medicine, NGS & CDx, combining technical and regulatory expertise to guide IVDs through CE certification and clinical trials, ensuring compliance with EU IVDR.
Marketa Svobodova, PhD
Regulatory Director, Precision Medicine
Quality & Regulatory Affairs leader with global IVD expertise, guiding products to compliance across EU IVDR, FDA & beyond.
Alice Toomey-Smith
Regulatory Director, IVD
IVD Director at MDxCRO with over 5 years of experience in the diagnostics and in vitro diagnostics space. Specializing in IVDR regulatory strategy, Catarina supports MedTech and diagnostics companies in navigating the evolving European regulatory landscape.
Catarina Sepúlveda PhD.
Regulatory Director | IVD Team
Senior Clinical Research Manager and biomedical engineer, expert in study design and clinical operations, MDR/IVDR regulatory compliance, GCP, CDx, and precision medicine.
Yaiza Benito
Clinical Development Lead | Precision Medicine
PhD in Systems Biology, a Master’s degree in Biotechnology and Cell Biology, and a degree in Biology, with training rooted in molecular genetics, cell biology, and translational biomedical research.
Andreia Henriques PhD.
Regulatory Affairs Specialist
Senior quality & regulatory expert, ISO 13485/MDR/IVDR auditor with expertise in CE marking MDs/IVDs, incl. dental, implantables, drug delivery, genomic tests, & MDR/IVDR implementation.
Andre Moreira
Regulatory Director | Strategic Support Team
Molecular genetics and biomedical sciences professional with over seven years’ experience in NGS workflows, quality assessment, and cancer therapeutics research.
Joana Silva
QA/RA Specialist
Specialist in oncology and radiation therapy clinical activities, clinical research manager with broad experience across medical devices and clinical operations.
Catarina Pragana
Associate Director Clinical Research
Clinical Research Pro, expertise in IVDR/MDR & ISO, leading trials in medical devices, IVDs & companion diagnostics across regions
Katharina Peters, PhD
Clinical Research Director
Quality & Training Manager and Senior IVDR consultant with expertise in CE marking, Clinical Laboratories, SaMD, Precision Medicine, Quality Assurance, and academic lecturing.
Hugo Leis, PhD
Knowledge & Training Manager | Quality Manager | Senior QA/RA Consultant
Clinical Research Lead in medtech, with expertise in CDx, MDR/IVDR, FDA/EMA and clinical operations management.
Begoña Fernandez
Clinical Research Lead
Principal RA Consultant IVD, life sciences academic background with a Biochemistry degree by Universidade do Porto and a PhD in Molecular Biosciences by Universidad Autonóma de Madrid.
Virginia Gondar, PhD.
Principal QA/RA Consultant
Clinical Research Specialist with cardiovascular CRC MedTech experience and healthcare background, focusing on CRA.
Antonino Barbera
Clinical Research Specialist
Luis is an IT and cybersecurity professional with 8+ years’ experience in cloud, compliance, governance, and leading multidisciplinary teams.
Luis Pereira
IT Manager
Ana Sofia Silva joins MDx as a Clinical Research Specialist, bringing a strong scientific background and hands‑on experience in clinical operations across Europe.
Ana Sofia Silva PhD.
Clinical Research Specialist
Human Factors Engineer with an R&D background across medical devices and IVD, focused on building technologies that fit real clinical workflows and patient use.
Paula Galan
Human Factors Engineer
Cognitive scientist and UX researcher applying usability engineering to IVDs, CDx and MedTech under IVDR and FDA human factors guidance.
Francesco Chiossi, PhD.
Senior Human Factors Engineer
With more than 7 years of experience as Human Factors engineer, Achille Gautheron is interested in the evolution of medical devices and In-Vitro Diagnostic Devices to improve patient well-being and care provided by practitioners.
Achille Gautheron
Sr. Human Factors Engineer
Senior RA/QA consultant with Post-Market Surveillance, Clinical evaluation, Risk Management and Human Factor Engineering expertise supporting Medical Devices & IVDs
Xabier Arias, PhD
Senior RA/QA consultant
Clinical research lead with expertise as a CRA and submission specialist across MD, IVD, and drug studies.
Huiwen Xu, PhD
Clinical Research Lead
Medtech Manager with RA, QA & CRA experience (FDA, UK, MDR/IVDR, TGA), specialized in clinical evidence, IVF & drug–device combination products.
Victoria Bachiller
Medtech Manager | Senior QA/RA Consultant | MD PRRC
Clinical Research Lead in IVDs and CDx, clinical affairs, operations, and EU/UK data protection compliance.
Helen Chen
Clinical Research Manager
Global medtech expert with 20y in IVD/MD, regulatory consulting & clinical research across AUS, UK, EU, UAE & Switzerland.
Nicholas Wilson, PhD
Principal QA/RA Consultant
Healthcare professional with CDx & IVD experience, combining commercial, administrative, and management expertise with strong team leadership.
Patricia Fernandes
People and Culture & Operations Coordinator (HR Representative)
Regulatory affairs specialist with extensive experience in IVDR implementation, precision medicine, and software regulation, backed by hands-on laboratory and R&D experience in various biological disciplines.
Claudia Loureiro, PhD
QA/RA Specialist
Clinical Research Specialist with strong scientific background in clinical microbiology and expertise in regulatory compliance with ISO 13485 and IVDR.
Ana Dias, PhD
Clinical Research Specialist
Senior QA/RA consultant with MDR, IVDR, Usability/Human Factors and MDSW expertise, supporting MedTech and IVD innovation globally.
Floella Otudeko
Senior QA/RA Consultant
Clinical Research Lead in IVDs, CDx, and medical devices. Skilled in performance study submissions and clinical operations under IVDR/MDR, with focus on precision medicine and EU regulatory alignment.
Marta Crespo
Clinical Research Lead
Clinical research specialist (PhD) with expertise in oncology, regeneration, pathology; skilled in IVDR CDx EU submissions and MDR CEVs.
Fátima Manzano, PhD
Clinical Research Specialist
Clinical Research & Biostatistics Specialist with training in biotechnology and biostatistics, supporting data-driven clinical studies in the medtech sector.
Carmen Méndez Sánchez PhD.
Clinical Research Specialist
José holds a degree in Biotechnology and a Master’s in Biophysics. After several years in biomedical research, he transitioned into Regulatory Affairs and Quality Assurance, where he has spent more than six years supporting MedTech and IVD companies, with a particular focus on Software as a Medical Device (SaMD), AI-driven technologies, and regulatory compliance under the MDR and IVDR.
José Velázquez
Senior QA/RA Consultant
Regulatory Affairs Specialist in Precision Medicine with expertise in IVDR, NGS diagnostics, and clinical evidence generation.
Miriam Jauset, PhD
QA/RA Specialist
Joana has a background in genomics and molecular diagnostics, with a focus on next-generation sequencing (NGS) and precision medicine
Joana Guerra, PhD
QA/RA Specialist
Clinical Research Specialist/CRA in MedTech & IVD; MDR/IVDR, ISO 14155/20916, clinical monitoring & regulatory submissions.
Petrina Mosoroceanu
Clinical Research Specialist
Regulatory Affairs & PRRC professional specialized in IVDR, bridging molecular biology expertise with regulatory and quality frameworks.
Inés Eulálio
QA/RA Specialist | IVD PRRC
Clinical operations expert with focus on regulatory compliance and study set-up and oversight under ISO 14155 / 20916 and MDR / IVDR / FDA.
Álvaro Torcal
Clinical Research Manager
Clinical Research Lead & Biostatistician with 4+ years in pharma and medtech trials across EU and US, MDR & IVDR, and ISO 14155 & 20916.
Sonia Ferreira, PhD
Clinical Research Lead & Biostatistician
Clinical Research Specialist/CRA specialized in Clinical Operations, Study Start-Up and Monitoring across Medical Device and IVD studies under MDR/IVDR & ISO 14155/20916
Miguel Lucas
Research Specialist
Specialist in Quality Management Systems and Molecular Biology, applying NGS Technologies to advance Precision Medicine.
Pedro Penedo
QARA Specialist
A medtech professional with a biomedical engineering background, regulatory expertise (ISO 13485,MDR), and commercial operations experience.
Joana Figueiredo
Finance and Administration Coordinator (Purchases Representative)
Senior Medtech regulatory professional experienced in MDR and IVDR implementation, CE-marking high-risk devices, and FDA compliance.
Emma Cartwright
Senior RA Specialist
IVD Quality and Regulatory Specialist with expertise in IVDR, ISO 13485, CE marking & molecular diagnostics tests.
Monica Rodrigues, PhD
QARA Specialist
Marketing Manager with with a background in industrial design, strong focus on digital business strategy and sustainable growth.
Lucia Pallas
Marketing Manager
Regulatory affairs specialist & CRA with expertise in EU MDR/IVDR, CE marking, Biological Evaluations (dental), and clinical investigations & technical documentation for MDs & IVDs.
Diego Rodríguez Muñoz, PhD
QA/RA Specialist
Neuroscience & biotech professional focused on MDR and clinical research strategies for medtech.
Zuzanna Kietlinska
Clinical Research Specialist
Experienced clinical affairs professional specialising in performance study submissions and management under IVDR, with a focus on CDx and Precision Medicine.
Callum Pickett
Clinical Alliance Lead | Precision Medicine
Regulatory Affairs Specialist in MDR & IVDR with expertise in CERs, SVRs, literature review, and regulatory compliance.
Grace Chia, PhD
QA/RA Specialist
QA/RA Specialist supporting teams in clinical evaluations and regulatory compliance with ISO 13485, MDR, and international medical device requirements (FDA, Health Canada, ANVISA).
Joana Martins
QARA Specialist
