What is a Service+Tech Model? – The Fastest Path to Integrating AI into Regulatory Operations
Rohan Sathe
25 Jun, 2025
Over 9 years of expertise in the medical device and clinical trial industry, specializes in creating and reviewing Clinical Evaluation Reports (CERs) across various device classes and therapeutic areas.
Extensive experience in Software as a Medical Device (SaMD), Biostatistics, Post Market Surveillance (PMS), and Post Market Clinical Follow-up (PMCF).
Led multiple client projects, managed cross-functional teams, and provided resolutions to Notified Body observations.
Skilled in collaborating with regulatory affairs, clinical affairs, and quality assurance to ensure successful medical device development and compliance.
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