Theme Significant change under the transitional provisions Target Audience Manufacturer Products concerned IVD : legacy devices Documents mentioned Regulation (EU) 2017/746 Directive 98/79/EC MDCG 2020-3 Regulation (EC) 1272/2008 Regulation (EC) No 1907/2006 Q&A...
Theme Borderline between medical devices and medicinal products Target Audience Manufacturers Products concerned Borderline products Documents mentioned Directive 2001/83/EC Regulation (EU) 2017/746 Directive 93/42/EEC Regulation (EU) 528/2012 Directive 2004/27/EC...
After more than 20 years in medical device industry (manufacturing, quality and regulatory), I have started my new nexialist challenge in February 2022 as Quality Consultant with one main focus “THE PATIENT”, thus product safety. I worked for medical device supplier...
Graduated from a multidisciplinary course in Sport Ergonomics and Motor Performance at the Faculty of Sport Sciences of Luminy. I am currently in Master 2 Bio-Engineering of Tissues and Implants. As part of my end-of-study internship, I am joining Nexialist for a...
I joined nexialist in July 2016, after several years of experience in tourism and as a small business manager. Today, my experience and knowledge benefit nexialist’s team. I mainly assist administrative and financial work as well as management and organization. It is...
I joined nexialist on April 01, 2021 after 3 years of experience in the field of medical devices. I graduated as a biomedical engineer (ISIFC) in 2017 and then worked as a certification and validation engineer for an active medical device. I have developed skills on...
Graduated with a Master in Biomechanics, Ergonomics and Product Design and a Sports Coaching degree, I have always had health and safety in mind through product ergonomics and human movement. I joined nexialist in 2018 as a product compliance consultant specialized on...
I did my PhD. in Neurosciences in Montreal on the identification of new biomarkers for the early diagnosis of Alzheimer's disease. Then, I worked for 2 years in a company which develops implantable and connected medical devices for neurosurgery (class III). In charge...
I joined nexialist in September 2017. I intervene on product compliance and more specifically on software issues. I am involved in nexialist training sessions, customers accompaniment as well as files writing. My professional maturity, my double experience in computer...
I am graduated in business management and international marketing and I have been working for the last 15 years in marketing positions in France and abroad. My experience is mostly in the cosmetics and dietary supplements markets in which I have gained solid skills to...
