Dr. Ariadna Navarro has spent over five years in the MedTech industry, working across various therapeutic areas, focusing on cardiovascular, diagnostics and neurotechnologies. Her medical device industry experience includes working as a Clinical Research Scientist and Clinical Study Manager, gaining thorough knowledge in designing, setting up and conducting clinical investigations according to ICH/GCP guidelines, ISO 14155 and ISO 20916. Ariadna also has strong experience in Regulatory Affairs and Quality Assurance, with expertise in the European regulatory landscape (MDR 2017/745, IVDR 2017/746 and the MEDDEV/MDCG guidance documents). She is a certified ISO 13485 Lead Auditor with experience setting up medical device quality management system standards, aiming to support manufacturers in placing and maintaining their devices in the market. She has nearly a decade of experience in preclinical and clinical research in the fields of embryonic development, neurogenetics and cardiovascular sciences. She has collaborated with In Vitro Diagnostic (IVD) manufacturers, contributing to strategy design and the set-up of in vitro techniques for diagnosing various cardiovascular and neurological disorders.

Dr. Navarro graduated as a Biotechnologist (BSc) from the Autonomous University of Barcelona (Spain). She holds a Master of Genetics of Human Disease from UCL, London, UK, and a PhD in Cardiovascular Sciences from University College London. She is fluent in Spanish, English, Italian, and Catalan.

In addition to her work, Dr. Navarro is actively involved in teaching Medical Device and IVD regulatory and clinical landscapes in several professional master’s programs. She also contributes regularly to the PMFarma and Farmabiotec journals, writing insightful Regulatory Affairs/Quality Affairs articles.

CORE COMPETENCIES

• Solid expertise in structural heart medical devices (valve repair and replacement), Software as Medical Device (SaMD) and IVD genetic testing kits
• Authoring Clinical Evaluation Plans (CEPs) and Reports (CERs) and Performance Evaluation Plans (PEPs) and Reports (PERs) for CE-mark certification
• Accompanying the execution and implementation of Medical Device Regulation (MDR) and In Vitro Dagnostic Regulation (IVDR) gap assessments regarding Technical Documentation (TD), Clinical Evaluation and Quality Management System (QMS)
• Supervising preparation documentation to cover transitional provisions according to MDR Article 120 and IVDR Article 110
• Developing CE-marking strategy for medical device and IVD start-up manufacturers
• Developing and compiling TD according to MDR and IVDR Annexes II and III
• Supporting Sponsors in the selection and interaction with Notified Bodies
• Providing guidance to Sponsors in the communication with National Competent Authorities
• Conducting internal audits according to ISO 13485
• Regulatory and Quality department leadership, including process improvement, mentoring and performance management
• Management and execution of premarket and post-market clinical investigations worldwide, including feasibilitity investigations for first-of-its-kind medical devices
• Oversight of study management teams including Biostatisticians, Data Managers, Clinical Project Leads, Clinical Study Coordinators and contract Clinical Research Associates (CRAs)

RECENT PROJECTS

• Supported several manufacturers of legacy and well-established technologies transitioning to the MDR 2017/745 through the execution and implementation of gap assessments
• Successfully assisted manufacturers with responses to Notified Bodies and National Competent Authorities
• Led a 13485 QMS and TD internal audit for a medical device manufacturer, identified improvement areas and implemented the output of the internal audit—the Sponsor successfully underwent Notified Body assessment without major non-conformities

PUBLICATIONS

• JR Vieira, B Shah, S Dupraz, I Paredes, P Himmels, G Schermann, H Adler, A Motta, L Gärtner, AG Navarro-Aragall, E Ioannou, E Dyukova, R Bonnavion, A Fischer, D Bonanomi, F Bradke, C Ruhrberg, CR de Almodóvar. Endothelial PlexinD1 signaling instructs spinal cord vascularization and motor neuron development. 2022 Dec 21;110(24):4074-4089.e6. doi: 10.1016/j.neuron.2022.12.005.
• AG Navarro-Aragall, AR Plein, C Ruhrberg. Regulation and Function of Cardiac Neural Crest Cells. Reference Module in Biomedical Sciences (2018). Book chapter. https://doi.org/10.1016/B978-0-12-801238-3.65396-5.