Post-Market Clinical Follow-up (PMCF)

Dr. Alpa Ben is a Senior Subject Matter Expert in Medical Devices Team at Celegence. She brings over 13 years of experience in regulatory affairs and medical writing, with expertise in evaluating EU-MDR compliant documentation.

Her experience includes reviewing CEP, CER, SSCP, PMS, and PMCF and provide scientific justification for equivalence, state-of-the-art, benefit-risk analysis, and clinical claims, supporting compliance with EU MDR. She has worked across various therapeutic areas, including dentistry, cardiology, gastroenterology, nephrology, and diagnostic & interventional radiology.

Dr. Alpa Ben holds a Bachelor of Dental Surgery (BDS) from Rajiv Gandhi University of Health Sciences (RGUHS) and Post Graduate Diploma in Clinical Research and Pharmacovigilance. With her academic and industry experience, Dr. Alpa Ben supports global regulatory programs and contributes to compliant and efficient regulatory outcomes.

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.

Dr. Neha Keral brings over six years of experience in regulatory affairs and medical writing. She specializes in evaluating documentation compliant with EU-MDR, TGA Australia, SFDA Saudi Arabia, and HSA Singapore regulations.

Her expertise includes authoring and reviewing CEPs, CERs, SSCPs, PMS plans/reports, PMCF plans/reports, SOPs, templates, and work instructions. She provides scientific justifications for equivalence, state-of-the-art assessments, benefit-risk analyses, clinical claims, and responses to Notified Body observations, ensuring compliance with regulatory requirements across multiple regions, including the EU, Australia, Saudi Arabia, and Singapore.

Dr. Keral has worked extensively across diverse therapeutic areas, such as dentistry, gastroenterology, neurology, wound care, ophthalmology, otolaryngology, pulmonology, and diagnostic and interventional radiology. She also has extensive knowledge and experience working with SaMD devices. Her proficiency includes understanding ISO 13485, ISO 14971, and ISO 10993 requirements for documentation.

As a Life Sciences Doctorate, Dr. Neha Keral leverages her academic and industry expertise to support global regulatory programs and drive compliant, efficient regulatory outcomes.