Post-Market Clinical Follow-up (PMCF)

Dr. Alpa Ben is a Subject Matter Expert in Medical Device Services at Celegence, bringing over 12 years of experience in healthcare and regulatory affairs. With a background in Dental Surgery and clinical practice, she has worked across multiple domains, including Pharmacovigilance, Labeling, Risk Management, Complaints Handling, and Medical Writing.

She has extensive experience authoring and reviewing EU MDR-compliant regulatory documentation, including Clinical Evaluation Plans and Reports, Post-Market Surveillance Reports, and Summaries of Safety and Clinical Performance. Her expertise spans a wide range of therapeutic areas, including dentistry, cardiology, gastroenterology, endoscopy, dialysis, and diagnostic and interventional radiology.

At Celegence, Alpa serves as both an SME and a clinical reviewer, specializing in regulatory documentation for medical devices, from simple technologies to complex Medical Device Software. Her deep regulatory knowledge and multidisciplinary experience enable her to support clients in navigating the evolving medical device compliance landscape.

He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.

Fastest EU MAA approval for a monoclonal antibody in an ultra-orphan (at the time). Successfully guided a client through the PIP application process in 9 months (average is 18).

Deblina Rababi is an experienced regulatory professional specializing in medical device compliance under EU MDR. She has expertise in authoring and reviewing Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Literature Search Reports (LSR), Periodic Safety Update Reports (PSUR), Post-Market Surveillance Reports (PMSR), and Post-Market Clinical Follow-up (PMCF) documentation.

As an Associate Manager at Celegence, she ensures the development of high-quality regulatory submissions, supporting medical device manufacturers in achieving compliance. Her detail-oriented approach and regulatory expertise contribute to streamlined documentation and successful audits.

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 panellist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.

Dr. Neha Keral is an experienced regulatory professional specializing in clinical evaluation, PMS documentation, and medical writing for global regulatory compliance, including EU MDR, US FDA, TGA, MHRA, Health Canada, NMPA, and HSA. She collaborates with cross-functional teams to develop high-quality regulatory submissions across various therapeutic areas.

With a Ph.D. in Life Sciences focused on antimicrobial and anticancer research, Dr. Keral brings a scientific approach to regulatory strategy. At Celegence, she leads documentation processes, ensures compliance, mentors teams, and drives regulatory excellence in medical devices. Passionate about the intersection of science and medical innovation, she is dedicated to advancing regulatory solutions that impact healthcare.