Anne Leijsen

Anne Leijsen

Factory CRO

Anne Leijsen has a background in Biomedical Engineering, where she specialized in Neural Engineering (MSc.). She performed her studies in the Netherlands (University of Groningen), Czech Republic (Czech Technical University of Prague), and Ireland (Trinity College), providing her insight in medical and hospital procedures throughout Europe. With a general interest for all types of medical devices, and a particular interest in the clinical field, she joined Factory CRO in the Netherlands 3 years ago.

At Factory CRO, Anne is leading the medical writing team. The medical writing team is responsible for designing clinical studies (writing of study protocols) as well as reporting on the study outcomes (writing of study reports and/or scientific literature) for all types of studies: pre-market studies for market access in the U.S. or Europe, post-market studies to full-fill follow-up requirements, large or small, single center or multicenter. Lately, the team has become expert in performing clinical evaluations according to the MEDDEV 2.7/1 rev. 4 standard, as well as the requirements put forward in the European Medical Device Regulation. Since the introduction of the guidance standard, the team has been writing clinical evaluation reports for devices in a variety of medical specializations, approved by a variety of Notified Bodies.