Sara Van Wouwe Email & Phone Number

Mol, Be

As a seasoned consultant in IVD regulatory affairs, I specialize in navigating the complexities of the IVD-Regulation 2017/746. With expertise in reviewing and writing technical documentation, I assist clients in ensuring compliance with regulatory requirements. My experience extends to working closely with start-up companies, guiding them through the process of obtaining CE certification from notified bodies.

Device Compliance Expert In Vitro Diagnostics and Medical Devices with expertise in the IVD-Regulation 2017/746Qarad is a small but fast-growing company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the areas of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies. From our offices in Geel, Eindhoven and Turin we serve more than 150 customers worldwide

Device Compliance Assistant In Vitro Diagnostics and Medical Devices.Assisting in regulatory affairs, technical documentation (STED under the IVD-Regulation), the organisation of clinical performance evaluations, the writing of scientific validity reports, the classification of mixtures according to CLP regulation 1272/2008 and compilation of safety data sheets for IVDs according to REACHQarad is a small but fast-growing company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the areas of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies. From our offices in Geel, Eindhoven and Turin we serve more than 150 customers worldwide

In this role, I carefully explore the regulatory landscape to select interesting topics for our local events. These discussions serve as opportunities for us all to gain deeper insights into the complex world of regulatory affairs, which can often prove challenging to navigate. Responsibilities:• Develop and maintain a list of guest speakers - Analyze current trending topics in the field of regulatory affairs to develop an educational program of interest for the LNG events - Maintain a list of educational topics of interest for LNG events - Develop strategies for further engagement of the already established community of regulatory professionals

Thesis research on the effect of gluten on the gastro-intestinal system and psychological factors. Research is conducted with Prof. Jan Tack and Jessica Biesiekierski.

Uz Gasthuisberg

Internship in the hospital:- Nuclear medicine, medical administration, pneumology and surgical oncology- Skills performed: ECG, drawing of blood, placing catheter, clinical examination Internship in the lab:- Research on imaging of the heart where sheep were used