Essenvia is a cloud-based regulatory management software built for medical device companies to reduce errors across pre-market and post-market regulatory processes, and to guarantee faster regulatory approval for medical devices. Examples of submissions include 510(k), MDR (Technical Document) for CE Mark, Regulatory change assessments.
Essenvia helps simplify the workflow across all stages of a medical device starting from regulatory strategy, pre-market submissions and post-market maintenance and reporting. Essenvia provides up to date regulatory information such as product codes, standards and guidance documents. Essenvia also offers carefully designed suite of tools such as smart forms & templates, built-in automation to auto-populate repeated information, and collaboration capabilities to streamline regulatory workflow for a medical device.