Since 2021 Maria has joined the Qserve Group as consultant where she works as a medical writer for Clinical Affairs.
Maria about working at Qserve
I’m passionate about helping manufacturers to provide a suitable clinical evaluation that suits their profile. I have experience in working with engineering solutions in the orthopedic field. I look forward to expand my knowledge working with clinical evaluations of medical devices.
Maria holds a MSc in Biomedical Engineering from FH Aachen University of Applied Science, Germany and a PhD in Biomedical Engineering from Maastricht University, The Netherlands. Over the past 6 years she worked as a researcher in the Tissue Engineering and Regenerative Medicine field, where she acquired a broad interdisciplinary experience in material science, cell biology and biofabrication. In particular, she worked on projects aiming at developing injectable anisotropic hydrogels for tissue engineering applications, as well as 3D printed biodegradable implantable scaffolds for bone regeneration.
Her interest in translational science led her to collaborate in an animal pre-clinical study testing her designed materials. She has further completed a clinical research associate (CRA) training program, where she gained knowledge on clinical research regulations and monitoring of clinical trials.
As medical writer within Qserve, Maria is involved in planning and preparing Clinical Evaluations, varying from writing Clinical Evaluation plans and reports and performing literature searches to preparing Post-Market Clinical Follow-up strategies and plans. To do so, Maria uses her knowledge of Clinical regulatory requirements and works together with different disciplines across organizations with the aim to provide a suitable clinical evaluation that suits the profile of the manufacturer.
The key expertise area of Maria:
- Deep knowledge of state-of-the-art tissue engineering solutions in the orthopedic field.
- Clinical Evaluation of medical devices, including the preparation and review of Clinical Evaluation Plans and Clinical Evaluation Reports (MEDDEV 2.7.1/rev. 4 and EU MDR);
- Preparation of Literature Search Protocols and Data Collection Reports (MEDDEV 2.7.1/rev. 4 and EU MDR);
- Effective literature search and appraisal.
- Strong scientific and technical writing skills.
- Experienced in pre-clinical laboratory characterization methods of newly developed materials, including cell-based in vitro assays.
- Knowledge of ICH-GCP (Good clinical Practice) and clinical trials monitoring activities.