Dr. Kasturi Rao

Kasturi Rao holds a Doctor of Philosophy (Ph.D.) degree in Cancer Research and a Masters degree in Molecular Biology and Human Genetics.

She has 12 years of experience in the Life Sciences Industry, including 4 years of experience in Regulatory Writing for Medical Devices.

She has authored and reviewed various critical documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) documentation, Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) documents for medical devices. These documents adhere to EU Medical Device Regulation (MDR) and MEDDEV 2.7/1 Rev 4 guidelines, ensuring compliance and quality.

Kasturi Rao has extensive experience in handling end-to-end Post-Market Surveillance (PMS) documentation. This includes conducting literature reviews for Device under Evaluation (DUE) and State of the Art (SoTA), performing searches on clinical trial databases and Adverse Event (AE) databases, authoring SoTA documents, and creating high-level summaries of literature, clinical, and non-clinical test reports. At Celegence, she leads a team of medical writers who specialize in creating various regulatory documents such as CEPs, CERs, PMS Plans, Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-up Plans and Reports.