Sathvik Tumma

- Determined regulatory strategies and approval pathways for WERRTA inhalation products. e.g., EU MDR, CLP, REACH, & medicinal. - Developed SOPs for Clinical Evaluation, Software Validation, Working Environment and Infrastructure in alignment with MDCG and MEDDEV guidance. - Assisted in implementing a digital Quality Management System (QMS) in accordance with EN ISO 13485. - Collaborated on the rollout of a new eDMS (Meddevo) and managed data migration from the legacy system using project management tools.

- Developed and implemented a company-wide strategy for UDI compliance, including traceability and labelling requirements. - Developed SOPs on Unique Device Identification and product-related documents (device claims, labelling, IFU) ensuring compliance with EU MDR and ISO 15223-1. Master Thesis: Implementation of UDI for “Inhaler 2 go“: A comprehensive analysis & labeling process development (Grade: 1,3)

- Evaluated biocompatibility according to ISO 10993, including comprehensive literature review and development of test plan and analysis. - Analysed processes for compliance with 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