Céline Furne joined NAMSA in 2008. As a study director and scientific manager, Céline has been involved in the performance and safety evaluation of medical devices, including orthopedic implants, cardiovascular devices, dental implants, wound dressings and tissue-engineered devices. She has a strong background in evaluating the local tissue effects of implants and experience in evaluating the performance of various devices, such as the mechanical and antimicrobial performance of orthopedic medical devices.

She then progressed to her current role as Biological Safety Scientist in the Biological Safety and Validation team, where she writes ISO 10993-1 Biological Evaluation Reports, performs toxicological evaluations, responds to Notified Body and FDA deficiencies and mitigates adverse test results. Her expertise in preclinical studies and safety evaluation allows her to work with a diverse range of medical device companies.

Céline holds a PhD in Molecular and Cellular Biology from the University of Lyon (France). She is an authorized person for animal experimentation level 1 and experimental surgery. She is a member of the French Society of Toxicology.

CORE COMPETENCIES

• Working knowledge of FDA and EU MDR and other global medical device regulations, ISO 10993 series, ISO 14971 and vertical standards
• Writing and reviewing biological evaluation plans and biological evaluation reports in accordance with ISO 10993 and ISO 14971 for submission to FDA, Notified Bodies and other regulatory agencies
• Writing and reviewing leachable/extractable toxicity assessments in accordance with ISO 10993-17, ISO/TS 21726 and other relevant guidelines
• Authoring multiple responses to deficiency letters, particularly on issues related to biocompatibility and performance
• Writing gap analyses

RECENT PROJECTS

• Biocompatibility evaluation of a catheter for percutaneous fistula creation for FDA submission
• Change control assessment for a raw material used in multiple catheters
• Mitigation of adverse local tissue effects test results of an absorbable suture

PUBLICATIONS

• Danysz W, Nowag B, Hengl T, Kreymerman P, Furne C, Madeuf E, Höennscheidt C, Mraz Robinson D. Can Sodium Thiosulfate Act as a Reversal Agent for Calcium Hydroxylapatite Filler? Results of a Preclinical Study. Clin Cosmet Investig Dermatol. 2020 Dec 31;13:1059-1073. doi: 10.2147/CCID.S271760. PMID: 33408497; PMCID: PMC7781022.
• Furne C, Drevon-Gaillot E., Rouchier J, Urrutigoity J, Clermont G: Endovascular creation of a rabbit saccular aneurysm model, EuroPCR – Paris – May 2016. Poster
• Furne C, Begnier MEH, Letessier A, Correia C, Sousa RA, Reis RL, Clermont G: Functionalized collagen conduit implantation in a paraplegic rat model, TERMIS-EU 2016 – Upsalla – June 2016. Presentation and Poster

• Furne C: Functionalized collagen conduit implantation in a paraplegic rat model – Safety and Efficacy Studies, Tissue Engineering & Regenerative Medicine International Conference – Berlin – September 2016. Presentation