The Essenvia Blog
What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?
What is GSPR? The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR […]
What does FDA Cleared vs. FDA Approved mean for Medical Devices?
Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules […]
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 […]
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 a […]
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. Therefore, […]
Essenvia Spaces: All Your Medical Device Data In One Place
Being in charge of a device’s regulatory information is complicated enough. Being tasked with managing this type of data for […]
5 Reasons You Shouldn’t Submit Your 510(k) Submission Alone
In today’s conversation, we are going to discuss the top 5 reasons why you should not do it alone when submitting your 510(k) application.
The Top 5 Reasons The FDA Rejects A 510(k) Submission
If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. […]