Lucile has over 20 years of experience in biological sciences and more than 5 years of experience in the medical device (MD) and in vitro diagnostics (IVD) industry. She specializes in clinical and performance evaluation of devices in compliance with the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), with expertise across Class I to III medical devices and Class A to C IVDs.
At NAMSA, Lucile has led and contributed to more than 40 clinical and performance evaluation projects, including Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs). She has led systematic literature reviews, developed State of the Art (SOTA) analyses, and supported benefit-risk evaluations for a wide range of technologies, including molecular diagnostics, implantable devices, drug delivery systems, and software as a medical device (SaMD). She also supports Notified Body interactions, including deficiency responses and remediation activities.
Lucile previously worked in clinical laboratories in the United States, where she contributed to the development and clinical validation of laboratory-developed tests (LDTs) in infectious diseases and pharmacogenetics. She holds a PhD in Developmental Biology/Genetics from the University of Méditerranée (France) and completed postdoctoral training in cardiovascular research at the University of California, San Diego. She is also the author of several peer-reviewed publications and has contributed as a medical writer to a publication in the New England Journal of Medicine (NEJM).
CORE COMPETENCIES
- Clinical Evaluation (CEP, CER) and Performance Evaluation (PEP, PER) authoring and review
- Development of clinical evidence strategies, including State of the Art (SOTA) and benefit-risk assessment
- Systematic literature review and critical appraisal (MEDDEV 2.7/1 Rev.4)
- MDR (EU 2017/745) and IVDR (EU 2017/746) regulatory compliance and submission support
- Notified Body interactions, including deficiency responses and remediation activities
- Medical writing for regulatory and scientific documents (clinical evaluation and publications)
- Clinical evidence generation and data interpretation for regulatory submissions
- Expertise in in vitro diagnostics (IVD), molecular diagnostics, and medical devices (Class I–III)
- Post-Market Surveillance (PMS) and clinical/performance evaluation updates
- Client interaction, cross-functional collaboration, and contribution to project delivery
RECENT PROJECTS
- Client interaction, cross-functional collaboration, and contribution to project delivery
- Led performance evaluation activities for multiple Class B and C IVD devices, including development of Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), and SOTA to support IVDR (EU 2017/746) compliance and Notified Body submissions
- Authored Clinical Evaluation Reports (CERs) for Class IIa to III medical devices, including implantable and drug delivery systems, with development of clinical evidence strategies, SOTA, and benefit-risk assessments to support MDR (EU 2017/745) compliance
- Provided medical writing and literature evaluation support for a clinical study publication of an oncology diagnostic assay, contributing to a manuscript published in the New England Journal of Medicine (NEJM)
PUBLICATIONS
- Author/co-author of 10 peer-reviewed publications in developmental biology and genetics
- Key journals include PNAS, Circulation Research, Developmental Biology, and Development
