Rencontrez les experts qui garantissent la réussite réglementaire et clinique
Notre équipe fait la différence chez MDx — un réseau diversifié de professionnels chevronnés, d’anciens experts d’organismes notifiés, de chercheurs cliniques, de responsables AQ, de scientifiques titulaires d’un doctorat et d’innovateurs en technologies médicales qui collaborent pour garantir l’excellence à chaque étape du cycle de vie du produit.
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
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 Development
Senior med-tech expert & ex-Notified Body reviewer with deep experience in high-risk implants, orthopedics, dental & neurology.
Alberto Bardají
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
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.
IVD Director
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 Research Manager
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 Ph.D.
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, Medtech
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
Quality & Regulatory Affairs leader with global IVD expertise, guiding products to compliance across EU IVDR, FDA & beyond.
Alice Toomey-Smith
Regulatory Director, IVD
Luis is an IT and cybersecurity professional with 8+ years’ experience in cloud, compliance, governance, and leading multidisciplinary teams.
Luis Pereira
IT Manager
Molecular genetics and biomedical sciences professional with over seven years’ experience in NGS workflows, quality assessment, and cancer therapeutics research.
Joana Silva
Regulatory Affairs Specialist
Clinical Research Lead in medtech, with expertise in CDx, MDR/IVDR, FDA/EMA and clinical operations management.
Begoña Fernandez
Clinical Research Lead
Specialist in oncology and radiation therapy clinical activities, clinical research manager with broad experience across medical devices and clinical operations.
Catarina Pragana
Senior Manager Clinical Operations
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 RA Consultant IVD
Clinical Research Specialist with cardiovascular CRC MedTech experience and healthcare background, focusing on CRA.
Antonino Barbera
Clinical Research Specialist
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
Senior QA/RA consultant with MDR, IVDR, Usability/Human Factors and MDSW expertise, supporting MedTech and IVD innovation globally.
Floella Otudeko
Senior QARA Specialist
Clinical Research Pro, expertise in IVDR/MDR & ISO, leading trials in medical devices, IVDs & companion diagnostics across regions
Katharina Peters, PhD
Associate Director Clinical Affairs
Ingénieur en ergonomie ayant une expérience en R&D dans le domaine des dispositifs médicaux et des diagnostics in vitro (IVD), spécialisé dans la conception de technologies adaptées aux flux de travail cliniques réels et à l'utilisation par les patients.
Paula Galan
Ingénieur en ergonomie
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
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
Spécialiste en recherche clinique / CRA spécialisé(e) dans les opérations cliniques, la mise en place et le suivi d'études portant sur les dispositifs médicaux et les dispositifs de diagnostic in vitro (IVD), conformément aux réglementations MDR/IVDR et aux normes ISO 14155/20916
Miguel Lucas
Stratège en recherche clinique
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
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
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
Clinical Research Lead in IVDs and CDx, clinical affairs, operations, and EU/UK data protection compliance.
Helen Chen
Clinical Research Lead
Global medtech expert with 20y in IVD/MD, regulatory consulting & clinical research across AUS, UK, EU, UAE & Switzerland.
Nicholas Wilson, PhD
Principal RA Consultant
Healthcare professional with CDx & IVD experience, combining commercial, administrative, and management expertise with strong team leadership.
Patricia Fernandes
EA & BO Coordinator
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
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
Specialist in Quality Management Systems and Molecular Biology, applying NGS Technologies to advance Precision Medicine.
Pedro Penedo
QARA Specialist
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
Spécialiste en recherche clinique et biostatistique, doté d'une formation en biotechnologie et en biostatistique, intervenant dans le cadre d'études cliniques fondées sur les données dans le secteur des technologies médicales.
Carmen Méndez Sánchez PhD.
Stratège en recherche clinique
Regulatory Affairs Specialist in Precision Medicine with expertise in IVDR, NGS diagnostics, and clinical evidence generation.
Miriam Jauset, PhD
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
RA Specialist
Clinical Research Specialist/CRA in MedTech & IVD; MDR/IVDR, ISO 14155/20916, clinical monitoring & regulatory submissions.
Petrina Mosoroceanu
Clinical Research 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 & PRRC professional specialized in IVDR, bridging molecular biology expertise with regulatory and quality frameworks.
Inés Eulálio
RA Specialist
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
Un professionnel du secteur des technologies médicales, doté d'une formation en génie biomédical, d'une expertise en matière de réglementation (ISO 13485, RDM) et d'une expérience dans le domaine des opérations commerciales.
Joana Figueiredo
Coordinateur des finances et de l'administration (responsable des achats)
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
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
Training & Quality 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
RA Specialist
Professionnel des neurosciences et des biotechnologies spécialisé dans le règlement MDR et les stratégies de recherche clinique pour le secteur des technologies médicales.
Zuzanna Kietlinska
Spécialiste en recherche clinique
Regulatory Affairs Specialist in MDR & IVDR with expertise in CERs, SVRs, literature review, and regulatory compliance.
Grace Chia, PhD
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
Clinical research leader and MedTech entrepreneur with deep expertise in medical devices, IVDs & precision medicine, with global study experience.
David Tomé
President
