The Essenvia Blog

How to Document Risk in your 510(k)

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to […]

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company […]

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 […]

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 […]

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. […]