Essenvia

Essenvia is a platform designed to expedite the regulatory submission process for medical devices, targeting small to large-sized medical device companies. According to the vendor, Essenvia is utilized by regulatory affairs professionals, quality assurance professionals, compliance officers, medical device manufacturers, and biotechnology companies. The platform offers a range of features and capabilities to streamline the submission process and save time and effort for users.

Key Features

Zero Implementation: According to the vendor, Essenvia requires no technical implementation or IT training, allowing users to start using the platform immediately.

Faster Submissions: Essenvia aims to accelerate the approval process for medical devices by potentially saving up to 4 weeks per submission. The platform allows for the easy assembly of complex libraries of technical files, auto-completion of new submissions using past submission information, and parallel collaboration among stakeholders.

100% Assurance: The vendor claims that Essenvia has a proven track record of a 100% acceptance rate in over 300 submissions. The platform provides intelligent error checking, intuitive walk-through wizards, and customizable templates to maximize acceptance and minimize common rejection issues.

Easy Transition to eSTAR: Essenvia aims to assist medical device companies in adapting to the FDA's mandatory eSTAR submission process for 510(k) submissions. The platform offers a digital walkthrough of eSTAR questions, mapping of custom templates, live editing with multiple stakeholders, and automatic mapping and preview of attachments.

Reusable Data for Faster Submissions: According to the vendor, Essenvia allows for the storage and re-use of past submission information, eliminating redundant content and attachments. This feature aims to streamline subsequent submissions and reduce content sprawl across multiple repositories.

Regulatory Alerts: Essenvia provides intelligent alerts for competitors, indications, recalls, and other events by delivering relevant market information from regulatory authority data feeds. Users can stay informed about 510(k) summaries, new standards and guidance documents, and competitive intelligence.

Streamlined MDR Submissions: Essenvia aims to simplify MDR/IVDR submissions by providing reusable content, pre-built templates, and collaborative content authoring. The platform enables file requests to collaborators, co-authoring of submissions, and direct collaboration within each submission, eliminating manual status trackers and redundant content.

Zero Implementation for EUMDR/IVDR: According to the vendor, Essenvia requires no technical implementation or training for EUMDR/IVDR submissions. Users can allegedly start their submissions within minutes, without the need for integrations or additional setup.