Séverine Oudin-Fantin has been in the healthcare industry for 19 years, with 15 years focused on medical devices. She has focused specifically on Reconstructive Surgery, Orthopedics, Neurology and Neurosurgery.

Séverine started working at NAMSA in 2017, where she currently manages EMEA Medical Writing Services and is responsible for the training of the medical writer team. Previously, she worked as a Principal Medical Writer and Team Leader and was involved in the preparation of Clinical Evaluation Reports (CER) for medical devices under MDD and MDR requirements. She has worked on a wide range of medical devices across all classes and various therapeutic areas. Additionally, Séverine has been involved in the development of procedures and templates for clinical evaluation processes in her different positions.

Séverine began her career as a consulting medical writer in 2005, specializing in clinical studies. She joined the MedTech industry in 2009 in the Clinical Affairs department at Integra LifeSciences. Séverine has a strong scientific background with a PhD in Biology obtained from the University of Geneva in 2004, focused on the effect of mechanical ventilation on lung cells.

CORE COMPETENCIES

• Managing project timelines and resourcing for medical writing projects
• Providing mentorship and leadership to the medical writing team
• Authoring and reviewing Clinical Evaluation Plans and Reports per EU MDR 2017/745 covering a variety of strategies (MDR article 61 section 10, well-established technology, legacy devices, implantable/ class III, combination devices)
• Authoring and reviewing systematic literature reviews for product development, post-market surveillance, clinical affairs, or marketing purposes
• Authoring and reviewing protocols, study reports and other deliverables in conjunction with clinical teams
• Authoring and reviewing scientific articles and abstracts, managing the publication process related to clinical studies
• Assisting Sponsors with responses to queries from regulatory bodies

RECENT PROJECTS

• Worked with several Sponsors on transitioning Clinical Evaluations in order to meet MDR requirements
• Successfully assisted Sponsors with responses to Notified Bodies

PUBLICATIONS 

• Goldbloom, D. et al. A new “tension side” locking plate for Hallux Valgus: A prospective multicentre case series. Foot and Ankle Surgery 22, 103–108 (2016).
• Schiavon, M. et al. The Use of Integra Dermal Regeneration Template Versus Flaps for Reconstruction of Full-Thickness Scalp Defects Involving the Calvaria: A Cost-Benefit Analysis. Aesthetic Plastic Surgery 40, 901–907 (2016).
• Wassink, S. et al. A Prospective 24 months follow-up of a three component press-fit prosthesis for hallux rigidus. Foot and Ankle Surgery (2016).
• Coillard, J.-Y., et al. Stabilization of proximal interphalangeal joint in lesser toe deformities with an angulated intramedullary implant. Foot & Ankle International 35, 401–407 (2014).
• Chaleat-Valayer, E. et al. A French observational study of botulinum toxin use in the management of children with cerebral palsy: BOTULOSCOPE. European Journal of Paediatric neurology 15, 439–448 (2011).
• Chevret-Measson, M. et al. Improvement in quality of sexual life in female partners of men with erectile dysfunction treated with sildenafil citrate: findings of the Index of Sexual Life (ISL) in a couple study. The Journal of Sexual Medicine 6, 761–769 (2009).
• Oudin S. et al. Role of MAP kinase activation in interleukin-8 production by human BEAS-2B bronchial epithelial cells submitted to cyclic stretch. Am J Respir Cell Mol Biol. 2002;27(1):107-14
• Bechard D. et al. Characterization of the secreted form of endothelial-cell-specific molecule 1 by specific monoclonal antibodies. J Vasc Res. 2000;37(5):417-25.