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Essenvia

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2 reviews
  • 1 profiles
  • 1 categories
Average star rating
4.5
Serving customers since
2018

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Essenvia Reviews

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JL
John L.
12/03/2025
Validated Reviewer
Review source: Seller invite

Revolutionizes Regulatory Submissions with AI Power

I love Essenvia's new AI features, particularly for their efficient ability to construct over 50% of a regulatory submission for multiple countries based on an existing FDA submission. This capability not only streamlines the entire submission process but also ensures accuracy by identifying gaps needed to complete a submission comprehensively. Essenvia's AI impresses me with how it utilizes previous regulatory submissions and interactions with the FDA to draft new submissions that meet previously identified requirements or discrepancies. The AI can effectively discern essential components of a submission based solely on a device's description or overview, saving me significant time and effort. Furthermore, I am impressed by the software's ability to automatically create tables of contents and tables of tables & figures, and even generate a complete eCopy submission immediately after last-minute edits. I also appreciate how user-friendly the setup was, with Essenvia's staff always available to address questions. This responsiveness aids in a smoother transition from manual submission creation, underscoring the efficiency and support quality that Essenvia offers.
Sophia M.
SM
Sophia M.
Software Quality Engineer II at Terumo Medical
11/17/2025
Validated Reviewer
Review source: Seller invite

Effortlessly Manages Regulatory Updates

I appreciate that Essenvia is consistently rolling out updates, indicating that the product is always improving. This progression and attention to development is exactly the type of software my company values investing in. Although I'm not a direct user, I admire the culture and flexibility of their staff. Their team is highly receptive, especially when it comes to leveraging internal testing, which helps us avoid duplicate testing efforts. The initial setup of Essenvia was easy, which made the transition smooth. Overall, I rate it highly and would undoubtedly recommend Essenvia to others.

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HQ Location:
Los Angeles, US

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What is Essenvia?

Essenvia is a company that offers a cloud-based platform designed to streamline and simplify the medical device regulatory submission process. The platform helps medical device companies manage and automate their documentation and submissions for regulatory bodies like the FDA. Essenvia's tools aim to reduce the time and effort required for regulatory compliance, thereby accelerating the time-to-market for new medical devices. The platform is equipped with features such as collaboration tools, automated submissions, and document management, enabling teams to work more efficiently and effectively.

Details

Year Founded
2018