Sathvik Tumma

- Determined regulatory strategies & approval processes for WERRTA inhalation products. - Developed SOPs on Clinical Evaluation, Software Validation, Working Environment & Infrastructure. and assisted in setting up a QMS acc. to EN ISO 13485. - Collaborated in the introduction of a new eDMS (Meddevo) and handled operations of data migration from old system using project management tools. - Supported in establishing processes: design control, biological evaluation, CAPA, & handling non-conforming products.

- Developed company-wide strategy for implementing UDI requirements, including aspects of traceability and labelling. - Developed SOPs on Unique Device Identification & Product-related documents (Device Claims, Labelling, IFU) Master Thesis: Implementation of UDI for “Inhaler 2 go“: A comprehensive analysis & labeling process development (1,3)

- Evaluated biocompatibility according to ISO 10993, including comprehensive literature research and the development of a plan and analysis. - Analysed processes with regard to risk and quality management standards.

Specialisation in Medical Regulatory Affairs - Introduction to the pre-market phase in the approval process of medical devices. - Introduction to approval process of medical devices. - Principles in clinical trials, market introduction and market surveillance of medical devices. Master thesis: Final Grade 1,3