Clinical & Regulatory Consultant
Jorrit worked for +3 years as medical writer at Avania (formerly Factory CRO, Bilthoven, the Netherlands). At Avania, he worked mainly on clinical study documentation, clinical study reports, and Clinical Evaluation Reports.
He prepared and reviewed documents for low to high risk medical devices in several therapeutic areas. In addition, he helped companies in defining a clinical strategy for market access and post-market clinical follow-up.
The key expertise areas of Jorrit
- Development of clinical strategies for medical devices in the EU
- Prepare and review Clinical Evaluation Plan & Report in accordance with MDD/MDR/MEDDEV 2.7/1 revision 4
- Design and conduct of systematic database searches, critical appraisal and review of scientific literature
- Prepare and review post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plan, and summary of safety and clinical performance (SSCP)
- Prepare and review clinical study submission documents for pre- and post-market clinical studies in the European Union in accordance with the Medical Device Regulation and ISO 14155 (Clinical Investigation Plan, Investigator Brochure and Investiga-tional Medical Device Dossier)
- Reporting of clinical study results
- Design and review of clinical evaluation, PMS, PMCF and SSCP templates and procedures in accordance with the MDR
- Manage and conduct investigator-initiated clinical research
- Write scientific publications
- Perform standardized assessment of vascular imaging for planning and follow-up of endovascular aortic repair
- Clinical and technical knowledge of vascular procedures, in particular endovascular aortic repair
Jorrit about working at Qserve
'I like being in a team of regulatory, quality and clinical experts where we can learn from each other and help our customers in the best way'.
Jorrit Boersen studied Technical Medicine at the University of Twente (Enschede, the Netherlands) and obtained a master’s degree in Medical Imaging and Interventions. During his studies, he conducted several clinical internships in radiology and surgery. His 1-year specialization internship was in vascular surgery.
After his studies, he continued with clinical research in this field for his PhD. During his PhD, he was responsible for several surgeon-initiated research projects.
Learn more about our services within Clinical trials or Regulatory Affairs!