Nicola Revellin, France



Nicola Revellin, PhD
Senior Medical Research Scientist
Professional Expertise:

Microbiology/Reprocessing Validation

  • Provided multiple consulting services to manufacturers with Sterilization Validation projects (strategy design, Instruction For Use reviewing, writing protocols) for both single use and reusable devices to submit to FDA or for CE mark applications Provided multiple “on-site” training sessions to Notified Bodies on Sterilization Validation issues to comply with ISO 13485 and EU MDD 2007/47 requirements as well as ISO 17664, ISO 17665, ISO 11 137, ISO 11737…
  • Provided several training sessions to manufacturers with NAMSA Advisory Service Training series in Europe 
  • 6 years assisting manufacturers with developing appropriate Bioburden and sterilization validation for single use devices
  • 6 years assisting manufacturers with developing appropriate cleaning, disinfection and sterilization validation for reprocessed devices
  • 6 years assisting manufacturers with deficiencies and investigation regarding microbial contamination
  • Performed audits of clean rooms and related facilities for manufacturers to improve efficiency and compliance with regulations Successfully developed and implemented quality systems for GLP and ISO 17025 inspections for microbiology laboratories (including Clean room monitoring)
Regulatory
  • Prepared multiple Biological Risk Assessments, Gap analyses, and Change Control Assessments
Education:
University of Lausanne, Lausanne, Switzerland
PhD in Microbiology

Employment History:
  • NAMSA (2008 – Present)
  • Senior Medical Research Scientist
  • Supervisor Microbiology Medical Research Manager
  • Technical Advisor
  • Study Director Microbiology