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.

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.

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.

• 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.
• 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.

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