Dr. Ariadna Navarro has a strong scientific background with a PhD in Cardiovascular Sciences and  close to ten years of experience in preclinical and clinical research. During her academic career, she collaborated with In Vitro Diagnostic (IVD) manufacturers in the design of strategies and the set up of in vitro techniques to diagnose several cardiovascular and neurological disorders.

Dr. Navarro’s medical device industry experience includes working as Clinical Research Scientist and Clinical Study Manager, gaining thorough knowledge in the design, set-up and conduct of clinical investigations according to ICH/GCP guidelines, ISO 14155 and ISO 20916. Ariadna has also developed a strong experience in Regulatory Affairs and Quality Assurance, and she has expert competence on 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 in setting up medical device quality management system standards aiming to support manufacturers placing and maintain their devices in the market.

Ariadna Navarro is a Biotechnologist (BSc) who graduated in 2012 from the Autonomous University of Barcelona (Spain). She has a Master of Genetics of Human Disease (UCL, London, UK) and a PhD in Cardiovascular Sciences from University College London. Ariadna is fluent in Spanish, English, Italian and Catalan.

CORE COMPETENCES

• 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