PMA vs 510K: Understanding the Differences in Premarket Approval for Medical Devices

When it comes to getting a medical device approved for market, there are two main routes manufacturers can take: premarket approval (PMA) or premarket notification (510(k)). Both are regulated by the Food and Drug Administration (FDA), but they have different requirements and different levels of scrutiny. In this article, we will explain the key differences […]

Premarket Approval 101: A Comprehensive Guide to the PMA Process for Medical Devices

The premarket approval (PMA) process is a rigorous and comprehensive evaluation of medical devices by the Food and Drug Administration (FDA) to ensure their safety and effectiveness before they can be marketed to the public. In this article, we will provide an overview of the PMA process, including the types of devices that require PMA, […]

The Importance of Clinical Data in Premarket Approval Submission for Medical Devices

When a medical device manufacturer wants to bring a new product to market, they must go through a rigorous premarket approval (PMA) process with the Food and Drug Administration (FDA). One of the most critical components of this process is the submission of clinical data to demonstrate the safety and effectiveness of the device. In […]

Improvita Successfully Completes Human Factors Validation Program Supporting Beyond Air’s LungFit® PH FDA Approval

MADISON, Wis., Aug. 16, 2022 /PRNewswire/ — Improvita, Inc., a Madison-based company affiliated with Innovenn, Inc., that focuses on human factors testing, ethnographic field research, user interface testing, and user experience testing for medical devices, software as a medical device, and combination drug / medical device products, is celebrating the approval of Beyond Air’s LungFit® PH […]

Get to Know the Innovenn Team – Annie Lutz

Annie Lutz has been with Innovenn since 2014—from a lean start-up to the current high-growth period. Over the years, she has she has demonstrated both personal and professional growth because of the opportunities she has been given she wears many hats and grows with each new experience prompting her full engagement and commitment to Innovenn. […]

The Importance of Understanding the End User

When developing a medical device, there are a lot of important considerations. Learn more about why starting with the end user is a critical first step from Innovenn’s Director of Medical Device and Digital Innovation, Annie Lutz.    

Get to Know the Innovenn Team – Deb Lovelace

Innovenn’s Human Resources and Executive Operations Manager, Deb Lovelace, is a force to be reckoned with. However, she is not a force like a powerful wind, or raging storm, rather Deb is consistent and steadfast. She is a natural caretaker, ensuring the team has exactly what they need to be effective, yet she still finds […]

Get to Know the Innovenn Team – Adam Vepraskas

After your first meeting with Innovenn’s Director of Regulatory Operations, Adam Vepraskas, you might describe him as intelligent, thoughtful, and well-spoken, and you would be correct. However, there is so much more to Adam than those three adjectives. Recently we took some time to learn a bit more about Adam’s career path, and what motivates him as he serves clients, co-workers, […]

The Innovenn Culture – People Matter

Creating a corporate culture that resonates with your team takes hard work, persistence, and consistency. Nurturing this culture is a critical part of developing an organization where people thrive and enjoy coming to work each day. In this edition of the Innovenn Minute, CEO Mary Dixon explains how she developed our corporate culture and what […]

Get to Know the Innovenn Team – LuAnne Farr

Process-driven, team-focused, strategic-thinker – when asked to describe LuAnne Farr, Innovenn’s  Director, Operations, these might be a few of the phrases that come to mind. LuAnne is an integral part of our success. Recently, we had the opportunity to learn a little bit more about the path that led her to our organization, and what she […]