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Submission: On September 21 via manual from US — Scanned from DE
Effective URL: https://essenvia.com/
Submission: On September 21 via manual from US — Scanned from DE
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Available Now: Complimentary eSTAR Office Hours with our experts Know More 510(k) eSTAR EU MDR/IVDR Blog Contact Login Watch Video Get a Demo New Webinar | September 21st Crossing the eSTAR Chasm: Transitioning to FDA’s Mandatory 510k eSTAR Submission Process by October 2023 Register Now THE LEADING PLATFORM TO ACCELERATE MEDTECH REGULATORY SUBMISSIONS Start using Essenvia today to accelerate the clearance of your FDA 510(k) submissions and EU MDR & IVDR CE certifications. See it in Action Get a Demo Zero Implementation. Start Using Today. * Company logo of Vios * * Company logo of Sleepiz * * * * * Company logo of Vios * * Company logo of Sleepiz * * * * * Company logo of Vios * * Company logo of Sleepiz * * * * * Company logo of Vios * * Company logo of Sleepiz * * * * FDA 510(K) CLEARANCE Use Essenvia to easily transition your 510(k) submissions to eSTAR Learn More EUMDR/IVDR Use Essenvia to rapidly create your EUMDR/IVDR submissions Learn More Why Essenvia? Zero Implementation Start using Essenvia today and realize benefits in the first week Faster Submissions Save up to 4 weeks per submission and get your medical devices to market faster 100% Assurance Essenvia has been used in more than 300 submissions with a 100% acceptance rate "Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions. We can’t live without the platform.” JOHN LANSDOWN GM - Quality, Regulatory and Compliance GET 30%+ FASTER WITH EVERY SUBMISSION Easily assemble complex libraries of technical files and auto-complete large portions of new submissions by re-using documents and device information from past submissions in your master library. SAVE 4+ WEEKS PER SUBMISSION Have technical files and content come to you by requesting stakeholder contributions and by bringing all stakeholders in parallel, safely, and securely into your regulatory submission drafting process. GET 100% ACCEPTANCE Intelligent in-line error checking, intuitive walk-through wizards and proven yet customizable templates maximize acceptance by eliminating common rejection issues. MONITOR COMPETITORS & REGULATORY CHANGES Create intelligent alerts for competitors, indications, recalls and other events, bringing relevant market information to you directly from the regulatory authority’s data feeds. ZERO IMPLEMENTATION. START TODAY. Essenvia requires no implementation to get going, which means you get going faster. We did it smart. And we keep it simple. See it in Action Terms of Use Privacy Policy Contact Us © Essenvia 2023. All rights reserved.