Showing results for:
Soumya Mahapatra
Chief Executive Officer, Essenvia
Articles
Your Guide to the FDA eSTAR program
eSTAR program and how to prepare for a smooth transition
FDA
Regulatory Operations
Your Guide to European CE Mark for Medical Devices
Your Guide to European CE Marks for Medical Devices Launching a new medical device is a highly regulated process whether […]
EU
Regulatory Operations
510k vs PMA Submissions for Medical Devices in the United States
When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is […]
510(k)
Regulatory Operations
How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission
Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts
Product Updates
Regulatory Operations
What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy
Overview Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit
Product Updates
Regulatory Operations
How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations
When you are in the early stages of developing a medical device, over half of your activities are regulatory-related.
Product Updates
Company News
Essenvia Product Workspace: All Your Medical Device Data In One Place
Being in charge of a product’s regulatory information is complicated enough.
Company News
Product Updates
