Barcelona, Catalonia, Spain
Founder of MDx CRO a specialized clinical research and regulatory consultancy dedicated to the medtech IVD sector. As a seasoned consultant in clinical and regulatory affairs, I am experienced in navigating complex regulatory challenges for top IVD companies. I have the privilege of serving as an external expert for the EU Commission and having lead global regulatory projects at BSI, one of the largest Notified Bodies as an IVDR CE mark technical expert. My portfolio of satisfied clients includes renowned companies such as Biomerieux, Cepheid, Leica (Danaher), Hologic, Grifols, Abbott, Beckman Coulter, ThermoFisher Scientific, Instrumentation Laboratory (Werfen), Roche Diagnostics, Alere, and more. I am passionate about simplifying science and regulation for my clients, delivering tailored solutions that help them stay ahead of the competition. My secret to success is building relationships based on trust, expertise and kindness. My clinical background, combined with 15+ years in the IVD industry and regulatory authorities, makes me a valuable resource for clients of all sizes. Let's connect and find out how I can help you navigate the ever-evolving world of IVD and MedTech 💬 ▪️Successes: ✔️2022 Led IVD content marketing strategies and increased new leads by >400%; signed MSAs with 4 new billion dollar diagnostic companies. ✔️2019 Successful implementation of the largest regulatory change affecting diagnostics in Europe, the in-vitro diagnostics regulation 2017/746 at 2 Notified Bodies - BSI UK and BSI Netherlands. ✔️ 2018 BSI's first IVDR in-house clinician. Responsible for clinical oversight of hundreds of diagnostics for the top 25 IVD companies. ✔️2015 Approval of the first HIV self-tests CE marked for home use in Europe, a key milestone that has improved accessibility to HIV testing in the region. Subject matter expert in test usability and post market requirements. ✔️ 2014 At the forefront of the Ebola crisis in Europe. Managed hospital and laboratory preparedness for emerging infectious diseases at Guy's and St Thomas' Hospital in London. ✔️2014 MHRA transition to new EU guidelines on Good Distribution Practice (GDP) of medicinal products for human use, provided training to industry and other stakeholders. ✔️2010s As a Lead Scientist in the London Transfusion Action Group (NHSBT) led emergency response to terrorism and other major incidents.
At MDx CRO, I lead a precision medicine-focused CRO and regulatory consultancy supporting MedTech, IVD, and pharma companies in bringing high-impact diagnostic solutions to market. We specialize in regulatory strategy, clinical validation, and performance studies across Medical Devices, IVD and CDx. Our work spans early development to commercialization—accelerating approvals, ensuring compliance, and unlocking market access. We partner closely with pharmaceutical companies on CDx strategy and development, aligning diagnostics with drug pipelines to enable personalized therapies and maximize clinical value. With proven expertise in NGS, PCR, ISH, liquid biopsy, immunoassays, software-based IVDs, and Point-of-Care technologies, we deliver tailored solutions that reduce risk, cut timelines, and drive commercial success. MDx CRO is more than a service provider—we’re a strategic partner in transforming science into scalable, regulatory-ready products.
Co-founded ICEPS to lead global alignment in clinical evidence for medical devices and IVD. Driving strategy, cross-sector collaboration, and innovation to elevate standards across the medtech ecosystem.
Provides opinion and advise on the preparation, implementation and evaluation of EU programmes and design of policies in the MedTech, Digital Health and Artificial Intelligence sectors Evaluation of Horizon 2020 proposals and their eligibility for funding based on excellence, impact and implementation. Prize applications and tenders.
Development of competitive intelligence & innovation strategies to drive business expansion, marketing initiatives and commercialisation in the medtech consultancy sector. Responsible for overall strategic direction and leadership for diagnostics Providing technical thought-leadership on strategic and complex client engagements, including regulatory strategy, technical and scientific input on IVD lifecycle management for the world's leading diagnostic companies. Range of technologies covered: companion diagnostics (CDx), NGS, molecular diagnostics, genetic testing, PoC, immunoassays, IVD Software and more. Monitoring of market, customer, regulatory and competitor trends in the diagnostics industry Spokesperson at congresses, regulatory conferences and industry committees.
Offered advice and solutions that solved complex market and customer challenges and ensured RQM+ employees were armed with the technical information and tools necessary to build knowledge and confidently deliver service excellence. Reporting to the SVP on all diagnostic related matters.
Lead a global, high-performing team of IVD experts in the US and Europe. Responsible for team recruitment & growth. Successfully implemented new EU medical device legislation (IVDR) across two EU Notified Bodies Clinical lead: reviewed product clinical performance, technical documentation and made CE certificate recommendations for IVDs. Trained and qualified product experts to assess IVD Design Dossiers & Technical Files (CE Marking): NGS, molecular, CDx (companion diagnostics), immunoassays, lateral flow technologies, and more Stakeholder engagement in the field of medical devices and participation in key EU medical device forums: MDCG, Competent Authority, EU commission, BIVDA, EMA Implemented effective training tools to support the development of global virtual teams.
Responsible for small to global CE and ISO certification projects. Monitored technical deliverables, project workflows and performance. Implemented the Notified Body process for reviewing IVDR clinical performance. Assessed all aspects of IVD technical documentation/regulatory submissions, including performance evaluation, risk management, product development and manufacturing. Performed batch verification and product release for high risk IVDs Subject matter expert in key diagnostic areas including immunohematology, transfusion medicine, rapid HIV testing and blood glucose monitoring. Worked on the regulatory approval and CE marking of the first HIV self-tests in Europe. Coordinated the Notified Body review of medical device vigilance reports and closure.
Audited a variety of businesses from small start-ups to large multinational organisations for compliance with medical device quality systems and risk management standards. Trained and qualified new auditors. Extensive international travel experience conducting routine and unannounced audits at manufacturing facilities in Europe, US and APAC