Deepika Pothiraju

Background

About Deepika Pothiraju

Biologist and trained professional in Regulatory Affairs MDR 2017/745 and IVDR 2017/746. As a Biologist, having strong expertise in the field of liver cancer biology, specifically in oncogenic signalling, and postdoctoral experience in liver biology of HIV conditions. Experienced in cancer biology, molecular biology, and cell biology areas, also hands-on in clinical research and scientific writing. As a Regulatory expert, working efficiently on-GAP analysis of Technical Documentation of Medical Devices and In-Vitro Diagnostic devices-Drafting STED, Biological Evaluation Plan, Clinical Development Plan, Clinical Evaluation Plan and Report -Drafting SSCPs (Summary of Safety and Clinical Performance) gap assessment-FDA, NMPA regulations (IVD devices clinical studies)-NIOSH and EUA documents drafting-Device design inputs requirement from ISO Standards-MDR and IVDR Training material preparation-Preparation of templates and checklists for regulatory requirements. • Biological Evaluation Plan (BEP) • Biological Evaluation Report (BER) • Post Market Surveillance (PMS) • Post Market Clinical follow-up (PMCF) • Technical Documentation Passionate about learning new things, having analytical and strategical thinking, problem-solving, effective communication skills, multitasking, teamworking, ability to work independently, and good self-organization.