Sylvie joined NAMSA in 2000 as Study Director, where she focused on all types of In Vivo normative studies, including reprotoxicity and carcinogenicity studies. Since that time, Ms. Framery has joined NAMSA’s Consulting Group to provide regulatory consulting services to manufacturers on biocompatibility projects to support worldwide market approval.

CORE COMPETENCIES

• Preparing biological safety evaluation plans, biological risk assessments, change control assessments, toxicological risk assessments, gap analyses and expert reports
• Evaluating and summarizing biocompatibility and general toxicology data, ensuring compliance with relevant regulatory requirements and standards
• Providing training to manufacturers as an Instructor with NAMSA’s Training Series
• Providing on-site training to manufacturers on biocompatibility
• Providing training to Notified Bodies (NB) and French National Agency for Medicinal and Health Product Safety (ANSM) on biocompatibility
• Performing presentations at trade shows and NAMSA-hosted events
• Serving as subject matter expert in support of Medical Research Managers and Technical Advisors
• Participating in ANSM and U.S. Food and Drug Administration (FDA) on-site meetings to support Sponsors

• Active Member of ISO/TC 194 committee on Biological and Clinical Evaluation of Medical Devices, participating notably in working groups overseeing ISO 10993 parts 1, 3 and 22

RECENT PROJECTS

• Performed a biological risk assessment on a combination device supplied as nanoparticles
• Provided a virtual customized training session on biocompatibility to a Sponsor company
• Delivered Ad Hoc support on degradation products toxicity for an absorbable medical device