Amber will primarily focus on assisting customers with Post Market Clinical Follow-Up. Amongst this, Amber will review or write PMCF plans and surveys. She is based in the Netherlands.
Amber likes to come up with creative solutions for complex problems and to have a critical view. With her engineering background, Amber can understand complex technological medical devices and approach related issues with an analytical approach.
Amber about working at Qserve
I am passionate about assisting people. My professional goal is to ensure that technological medical devices with high safety and performance are progressing to the market and the patient. Within Qserve, I can combine this passion and goal with my colleagues.
Before working at Qserve, Amber studied Biomedical Engineering (BSc & MSc) at the Technical University of Eindhoven. During her academic studies, Amber was part of the research group Soft Tissue Engineering and Mechanobiology of professor C.V.C (Carlijn) Bouten. In addition, Amber followed a master's track in Regenerative Medicine and Technology, a collaboration with Utrecht University & University Medical Center Utrecht.
Amber contributed to several research projects regarding various cardiovascular devices. Examples of projects are 1) Tissue engineering vascular access grafts and 2) 3D-bioprinting a human myocardium in-vitro model to study fibrosis. The last task she conducted in a research center related to a university medical hospital.
Amber did her graduation project for the Hybrid Heart project. Amber had an advising role in this graduation project, wrote plans, and a novel research line within the HH project was initiated under the supervision of prof. C. Bouten. Amber's project focused on hemocompatibility, an essential part of the biocompatibility of blood-contacting medical devices.
During her academic studies, Amber participated in various extracurricular activities, such as the faculty council, several committees at different associations, and several student-assistant and tutoring roles. Also, Amber was a summer work student at a (cardiovascular/surgical robots) medical device company, where Amber a.o interviewed physicians to obtain feedback about the medical device design.
The key expertise areas of Amber
- Knowledge of MDR and GCP: EU MDR 2017/745, EU MDR 2017/746, ISO14155:2020
- Advice to clients on medical devices:
- Medical writing and PMCF
- Scientific writing skills
- Literature search expertise
- Strong engineering background, understanding of complex technological medical devices, analytical problem-solving capacity, creative solutions for complex problems
- Strong technical knowledge of cardiovascular implantable medical devices
- Forming a bridge between MD technology and the clinic, obtaining and reporting physician feedback on medical devices
- Medical device design and manufacturing
- Themes: knowledge of biocompatibility (e.g., hemocompatibility (ISO 10933-4)), tissue engineering, regenerative medicine and technology, 3D-bioprinting/bio fabrication, cell-biomaterial interactions
- Strong communication skills and the ability to work in multidisciplinary and international teams
- Strong planning and organizing skills
- Languages: Dutch (native), English (proficient)