Parvathi Nambiar

Parvathi Nambiar has a Master’s degree in Microbiology and over seven years’ experience in medical writing for pharmaceutical and medical device regulatory affairs. She has authored and reviewed clinical evaluation documentation, post-market surveillance (PMS) documents, Clinical Investigation Plans (CIP), and Clinical Study Reports (CSR).

A subject matter expert at Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS plans, Post-Market Surveillance reports, Periodic Safety Update reports, Post-Market Clinical Follow-up plans, and reports, for devices from a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, implants, pulmonary, and female health products.

She has successfully addressed feedback from Notified Bodies like BSI, Intertek, DEKRA, and achieved MDR certification for new devices and MDD certified devices. She has also been a panelist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.