Britta Rupp, PhD

Britta is an accomplished professional with 20+ years of research experience spanning multiple scientific disciplines. Her journey in the medical device industry began at NAMSA in 2015 as a preclinical study director, later transitioning to consulting in 2019.

Britta has a PhD in neuroscience and a depth of experience in various therapeutic areas, including neuromodulation, cardiovascular/endovascular, and endoscopy/gastroenterology. She has spent the last 5+ years writing regulatory documents covering all classes of medical devices and has expertise in both EU and US regulations.

CORE COMPETENCIES

• Developing Clinical Study Reports (CSRs) according to ISO 14155:2020 and ICH/GCP guidelines
• Authoring and reviewing Clinical Evaluation Plans (CEPs) and Reports (CERs) according to MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745
• Conducting systematic literature reviews and data analysis
• Assisting clients with Manuscripts, Clinical Study Protocols, Regulatory Responses, and other documents
• Working cross-functionally with the clinical, statistics, regulatory, and safety teams to identify and distill the necessary information into cohesive, high-quality deliverables
• Guiding strategy through collaborative decision-making as the technical lead and client liaison
• Applying general scientific inquiry skills (e.g., study design, evaluation of results, critical thinking, etc.) to ensure scientific rigor and effectively communicate robust scientific stories

RECENT PROJECTS

• Response to Regulatory Authorities: Developed response to successfully address FDA deficiencies
• CSRs for PMA Submissions: Drafted CSRs, adhering to relevant regulatory requirements
• Investigator’s Brochure: Authored a comprehensive IB for submission to EU Competent Authorities