Jeanne CHAMOUSSET-ROMAN

Initially driven by the technological innovation of the medical device sector, I was sensitized by patient safety from my engineering course, which led me to Quality Assurance, thus allowing me to combine technological prowess and clinical requirements while continuously measuring the balance between Benefits and Risks Patient.
Developing the technical documentation with the objective of obtaining the CE marking quickly becomes a challenge allowing the success of beautiful projects. 

Then, wishing the possibility of access to all patients from all countries to the best care, I then took a liking to the challenges of export regulatory registrations (outside Europe).

Obtaining the ICA ISO 13485 certification allows me to carry out constructive internal audits for medical device manufacturers, but also on behalf of notified bodies or certification providers.
Today, in the midst of a transformation in the service of patient safety, the sector of regulatory affairs and quality system in medical devices is becoming even more exciting. This is why, after 15 years spent in Quality and Regulatory Affairs departments at medical device manufacturers, I decided in 2019 to put my skills at the service of manufacturers in the medical device sector.