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
Senior med-tech expert & ex-Notified Body reviewer with deep experience in high-risk implants, orthopedics, dental & neurology.
Alberto Bardají
Head of Medical Devices
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
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
Quality & Regulatory Affairs leader with global IVD expertise, guiding products to compliance across EU IVDR, FDA & beyond.
Alice Toomey-Smith
Regulatory Director, IVD
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
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
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
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
Healthcare professional with CDx & IVD experience, combining commercial, administrative, and management expertise with strong team leadership.
Patricia Fernandes
EA & BO Coordinator
Global medtech expert with 20y in IVD/MD, regulatory consulting & clinical research across AUS, UK, EU, UAE & Switzerland.
Nicholas Wilson, PhD
Principal RA Consultant
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
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
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 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
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
Regulatory affairs specialist & CRA with expertise in EU MDR/IVDR, CE marking, Biological Evaluations (dental), and clinical investigations & technical documentation for MDs & IVDs.
Diego Rodrigues, PhD
RA Specialist
Regulatory Affairs Specialist in MDR & IVDR with expertise in CERs, SVRs, literature review, and regulatory compliance.
Grace Chia, PhD
RA 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 Research Lead
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 Lead in IVDs and CDx, clinical affairs, operations, and EU/UK data protection compliance.
Helen Chen
Clinical Research Lead
Clinical research lead with expertise as a CRA and submission specialist across MD, IVD, and drug studies.
Huiwen Xu, PhD
Clinical Research Lead
Regulatory Affairs & PRRC professional specialized in IVDR, bridging molecular biology expertise with regulatory and quality frameworks.
Inés Eulálio
RA Specialist
Regulatory Affairs Specialist with deep expertise in IVDR implementation, Precision Medicine, and Software Regulation, supported by hands-on laboratory and R&D experience across biological disciplines.
Claudia Loureiro, PhD
RA Specialist
Regulatory Affairs Specialist in Precision Medicine with expertise in IVDR, NGS diagnostics, and clinical evidence generation.
Miriam Jauset, PhD
RA Specialist
Quality & Regulatory Assurance Specialist with expertise in MDR compliance, QMS, audits, and medical device documentation.
Joana Santos
QARA Specialist
Specialist in Quality Management Systems and Molecular Biology, applying NGS Technologies to advance Precision Medicine.
Pedro Penedo
QARA 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 (PhD) with expertise in oncology, regeneration, pathology; skilled in IVDR CDx EU submissions and MDR CEVs.
Fátima Manzano, PhD
Clinical Research Specialist
Clinical Research Specialist/CRA in MedTech & IVD; MDR/IVDR, ISO 14155/20916, clinical monitoring & regulatory submissions.
Petrina Mosoroceanu
Clinical Research Specialist
A medtech professional with a biomedical engineering background, regulatory expertise (ISO 13485,MDR), and commercial operations experience.
Joana Figueiredo
Assistant BO Coordinator
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
Neuroscience & biotech professional focused on MDR and clinical research strategies for medtech.
Zuzanna Kietlinska
Clinical Research Strategist
Clinical Researcher with 11+ years experience in CTs, CIs of MDs, PSs of IVDs, project management, regulatory submissions & medical writing.
Catia Caetano, PhD
Clinical Project Manager
UK-based consultant with 25+ yrs in pharma, medical devices & IVDs. Expertise in EU MDR/IVDR, helping global leaders bring tech to market.
Kara McNair, PhD
Principal RA Consultant
