Iconeus hires quality and regulatory affairs manager in readiness for clinical applications

The applications of our functional ultrasound technology continue to expand, and we’re currently devoting considerable energies to developing its potential in the clinic. One aspect of meeting this goal is of course working on the technical advances necessary to make functional ultrasound imaging viable in humans – for example, see these news items about our Iconeus One Clinical Research edition and a funding announcement for fULM technology.

But another equally important aspect is ensuring that our products meet the necessary regulatory requirements to be classed as ‘medical devices’. To that end, we’re investing in the staff needed to guide us along the right path, and we’re now pleased to have on board a dedicated Quality Assurance & Regulatory Affairs Manager, Aurélia Lefevre, Pharm.D.

Aurélia joined us in late 2022, and arrives with substantial experience of medical devices and regulatory compliance. She has had roles in medical device regulatory affairs at DentalMonitoring, Novomed Group and Church & Dwight, and has taken internships at Hillo, St-Louis Hospital, the Agence Générale des Equipements et Produits de Santé (AGEPS), and Cordeliers Research Center.

In addition, in 2021, Aurélia successfully defended her Pharm.D. thesis in Pharmacy at the University of Paris – a qualification that incorporated a ‘Master 2’ sandwich course in ‘Medical devices: Appraisal, registration, vigilance’, carried out at the University of Paris-Saclay.

In her new role, Aurélia has overall responsibility for developing our regulatory strategy, optimizing our quality management system, dealing with the relevant authorities for regulatory compliance, and defining the end-user applications for which we will seek regulatory certification.