Beatriz has a broad interest in healthcare, which has led to 15 years of experience across Regulatory, Medical Affairs, and Academic Research. She is currently working in Regulatory Consulting with an EU focus.
She has expert competence in European Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), and MDCG/MEDDEV guidance documents. Previously working as manager of the Regulatory Affairs department of an MD/IVD consulting firm, she hired and trained a team of more than 10 Regulatory Scientists and delivered projects including strategic consulting, Clinical Evaluations, MDD to MDR gap assessments, literature reviews, SSCPs, post-market documentation, and technical documentation. During her first years at NAMSA, Beatriz led a team of consultants focused on Clinical Evaluations of medical devices (MDs) and IVDs. Beatriz also teaches at several local University Master´s programs with a focus on MD and IVD.
Beatriz previously worked as a Clinical Study Manager, gaining solid knowledge of ISO 14155. Before moving into the field of MDs, she had a role in Medical Affairs in Pharma, which has given her a broad view of the Pharma and MedTech industry and the critical interactions between the different stakeholders.
Beatriz graduated as a Biochemist (BSc Autonomous University of Madrid, Spain) and holds a PhD in Neuroscience (The University of Manchester, UK), after which she did postdoctoral work at INCIA, a research institute in Bordeaux, France. She also holds an MSc in Clinical Research and Pharmaceutical Medicine (EPHOS, Spain), and an MRes in Medical and Molecular Biosciences (University of Newcastle, UK).
CORE COMPETENCIES
Regulatory/Quality
- Developing regulatory strategies and implementation plans for MD CE-marking and CE-mark renewal (from design phase towards CE-mark)
- Performing gap assessment and examination of conformity (compliance of documents for approval according to relevant regulations, rules and standards) with coordination of all concerned departments to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Developing:
- Quantitative Safety and Performance Objectives and Clinical Benefits for Clinical Evaluation (MD)
- Clinical/Performance Evaluation Plans and Reports, including WET and innovative devices (MD and IVD)
- SSCP and readability tests
- Systematic Literature Review according to MEDDEV 2.7.1/Rev 4, for State of the Art and device safety and performance (MD and IVD)
- Post-Market Documentation (PMS plan, PMCF plan, PSUR, MD)
- Compilation of Technical Documentation (MD/IVD)
Clinical
- Clinical study management including oversight of study milestones, revising compliance with required laws and guidelines, and acting as point of contact between international study field team, central business units, and upper management
- Clinical protocol development
RECENT PROJECTS
- Robotic Surgery medical devices, clinical development strategy, and clinical evaluation
- Legacy medical devices: Revision of client portfolio for strategic prioritization of MDD to MDR transition of products
- Innovative devices: AI SW clinical evaluation strategy
- Training to international manufacturers on MDR- and IVDR-compliant clinical evaluations and systematic literature review
- Publication of systematic review in collaboration with an international manufacturer to support therapy and device positioning in the context of the state-of-the-art
SELECTED PUBLICATIONS AND OTHER COMMUNICATIONS
MedTech:
- The newly applied European Health Technology Assessment (HTA) Regulation: implications for medical devices_2025. Article (Farmabiotec | HTA implications for MDs)
- Risk Management, Clinical Evidence and Post-Market Reporting_2024. Podcast (Risk Management, Clinical Evidence and Post-Market Reporting – NAMSA)
- Clinical Data Requirements Under MDR: A Panel Discussion._2024. Webinar (Clinical Data Requirements Under MDR: A Panel Discussion – NAMSA)
- Innovation and challenges in the IVD sector in Spain. 2024. PMFarma (https://www.pmfarma.com/articulos/3983-innovaciyin-y-retos-del-sector-de-diagnyistico-in-vitro-en-espaya.html)
- Emerging Med-Tech: challenges and strategic measures. 2023. PMFarma (https://www.pmfarma.com/revista-pmfarma/online/iframe.php/?link=37)
Peer-reviewed scientific articles:
- Dierick K, Rodriguez‐Grande B, Navarro‐Aragall AG, Beraud M. Quality of life in people with sickle cell disease treated with automated red blood cell exchange. Vox Sanguinis. 2024. Oct 22. doi: 10.1111/vox.13757
- Book chapter in Brain Edema – ISBN: 9780128031964, 9780128031971. Publisher: Academic Press Inc. Editors: Jerome Badaut Nikolaus Plesnila. Aquaporin in Brain Edema.
- Rodriguez-Grande B, Obenaus A, Ichkova A, Aussudre J, Bessy T, Barse E, Hiba B, Catheline G, Barrière G, Badaut J. Gliovascular changes precede white matter damage and long-term disorders in juvenile mild closed head injury. Glia. 2018 Aug;66(8):1663-1677. doi: 10.1002/glia.23336. Epub 2018 Apr 17. PMID: 29665077.
- Rodriguez-Grande B, Ichkova A, Lemarchant S, Badaut J. Early to Long-Term Alterations of CNS Barriers After Traumatic Brain Injury: Considerations for Drug Development. AAPS J. 2017 Nov;19(6):1615-1625. doi:10.1208/s12248-017-0123-3. Epub 2017 Sep 13. PMID: 28905273.
- Smith CJ, Lawrence CB, Rodriguez-Grande B, Kovacs KJ, Pradillo JM, Denes A. The immune system in stroke: clinical challenges and their translation to experimental research. J Neuroimmune Pharmacol. 2013 Sep;8(4):867-87. doi: 10.1007/s11481-013-9469-1. Epub 2013 May 15. PMID: 23673977.
- Other publications
