What is a Service+Tech Model? – The Fastest Path to Integrating AI into Regulatory Operations
Smridula Hariharan
24 Jun, 2025
Smridula Hariharan has a Master’s degree in Pharmacy, 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.
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