Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices

Webinar Sponsored by:

Our Distinguished Presenters:

Parvathi Nambiar
Team Lead, Medical Device Services
Celegence

Parvathi has a master’s degree in microbiology, and an overall 6 years of experience in Medical Writing for Pharma and Medical Device Regulatory Affairs. She has authored and reviewed post-market surveillance (PMS) documents and Clinical Investigation Plan (CIP) and Clinical Study Report (CSR).

At Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices belonging to 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, and female health products.

Anushree Singh
Associate Manager, Medical Device Services
Celegence

Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and Master’s degree in Bioscience (Human Genetics), and an overall experience of 6 years working as a researcher and lecturer.

She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas – all specialties of dentistry, radiosurgery, diagnostic imaging, neuro-oncology, hemodialysis, female reproductive health, and pneumothorax pulmonology.

At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance including Post-Market Clinical Follow-up, and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents such as Clinical Evaluation Plans and Reports, Post-Market Surveillance Plans and Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-up Plans. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, DEKRA, SGS, Eurofins Expert Services Oy) on the road to CE Marking of medical devices under EU MDR