EMA Roadmap Update: PMS Capabilities and the End of the Legacy Era
Rohan Sathe
25 Jun, 2025
Rohan Sathe holds an M. Tech in Biomedical Engineering from IIT Bombay and has over 10 years of experience in the medical device and clinical trial industry. He specializes in the preparation and review of Clinical Evaluation Reports (CERs) across multiple therapeutic areas.
His expertise includes EU MDR clinical evaluation, Software as a Medical Device (SaMD), Biostatistics, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF), along with addressing Notified Body observations.
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