Ruida Huang Email & Phone Number

Modena, It

Bologna, Emilia Romagna, Italia

I am a Clinical Project Manager specializing in in vitro diagnostic devices (IVDs), with extensive experience in helping Chinese manufacturers obtain CE marking through clinical studies that comply with European regulations. Thanks to my bilingual expertise in Italian and Chinese, I can communicate effectively with both Chinese manufacturers and Italian professors and doctors.In my role, I coordinate all phases of clinical trials from planning to implementation, ensuring that each phase is conducted according to international regulations and Good Clinical Practice (GCP) guidelines. I communicate closely with manufacturers' teams to fully understand the technical specifications of devices and facilitate communication between stakeholders and regulatory authorities.I am responsible for preparing required documentation for regulatory authorities, including study protocols, informed consents, and clinical reports. My attention to detail ensures that all documents meet the requirements of the IVD Regulation (IVDR), which are essential for obtaining CE marking.I manage the project budget, monitoring costs and ensuring efficient allocation of resources. I analyze clinical data to assess the safety and efficacy of IVD devices, preparing detailed reports for regulatory authorities and notified bodies.With an aptitude for problem solving and a strong ability to manage complexities, I strive to ensure that my clients' IVD devices are safe, effective, and ready for the European market. My expertise in cross-cultural communications and ability to work in international settings allow me to facilitate effective collaboration between Europe and China.If you are looking for an expert in clinical trials and regulatory compliance for IVD devices, I am here to help you successfully navigate the path to CE marking.

Modena, Emilia-Romagna, Italy

MECS MACHINERY ECONOMIC STUDIES

莫德纳地区

MECS MACHINERY ECONOMIC STUDIES

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