Company intelligence / Profile preview

eSTARHelper

Ownership: Private
Development stage: Other

Overview

eSTARHelper is an active US-based hybrid consultancy specializing in FDA regulatory affairs and Microsoft cloud/IT solutions for the medical device industry. The company offers tools such as SmartSearch+—an AI-powered platform integrating OpenAI’s ChatGPT—to streamline FDA 510(k) premarket submissions and compliance processes. It leverages its expertise to help clients manage complex documentation, quality systems, risk management, and digital transformation needs related to US FDA CDRH requirements.

Industry: Consulting

Partnerships

Microsoft Partner

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