Smridula Hariharan has a Master’s degree in Pharmacology, and over 12 years of experience in Medical Writing for Medical Device Regulatory Affairs as well as pharmacovigilance and clinical research. She has authored and reviewed post-market surveillance (PMS) documents for medical devices and invitro diagnostics belonging to different risk classes and therapeutic areas. She has successfully procured CE marking under MDD and MDR for novel as well as legacy products through comprehensive clinical evaluations, PMS plans, and PMCF plans/reports. She has also been involved in authoring and reviewing safety narratives, Clinical Investigation Plans (CIP), Clinical Study Reports (CSR), and developing SOPs and templates for a variety of PMS documentation.
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 spanning a wide range of therapeutic areas including cardiology (stents/ defibrillators/ valves/ guidewires/ catheters), dentistry (implants/screws/ cements, attachments/ abutments, kits as well as single products), radiosurgery, diagnostic imaging, in vitro fertilization (IVF), female health products, bandages/sutures/wraps, airway monitoring, BP apparatus, thermometers (digital and mercury), nephrology products (dialysis units and all its related accessories).