Adaptive Regulatory Submission Management
Arka Venture Labs Fund
First Rays Venture Partners
Essenvia is the pioneer in regulatory submission management for the MedTech industry. Unlike conventional Regulatory Information Management (RIM) tools, documents, or spreadsheets, Essenvia has zero technical implementation time and works seamlessly with a regulatory team’s existing process. The platform empowers teams to natively collaborate on 510(k), MDR and IVDR submissions directly inside of a submission, error check them, dynamically publish and re-publish them with one click, and instantly submit using the latest agency-specific technical requirements. This saves regulatory professionals dozens of painfully tedious hours wasted on researching information, eliminates submission errors, and radically shortens submission time to market. Essenvia has a 100% acceptance rate across hundreds of different types of complex global submissions including 510(k)s, MDR and IVDR tech files.