6410 Enterprise Lane, Ste. 230
Madison, Wisconsin 53719
Madison, Wisconsin 53719
Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.
These cookies are strictly necessary to provide you with services available through our website and to use some of its features.
We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.
These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.
If you do not want that we track your visit to our site you can disable tracking in your browser here:
We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.
Google Webfont Settings:
Google Map Settings:
Google reCaptcha Settings:
Vimeo and Youtube video embeds:
The following cookies are also needed - You can choose if you want to allow them:
Expert Design Control Services by Innovenn/in Uncategorized /by Innovenn
What are Design Controls? Design Controls are a set of product development processes and procedures that medical device manufacturers must follow to ensure that their products are safe and effective for their intended use. This process is utilized to confirm the medical device meets the user needs, requirements and intended uses. Controls for the design […]
PMA vs 510K: Understanding the Differences in Premarket Approval for Medical Devices/in Uncategorized /by Innovenn
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/in Premarket Approval /by Innovenn
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/in Premarket Approval /by Innovenn
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/in Press Release /by Deb Lovelace
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/in Uncategorized /by Deb Lovelace
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/in Uncategorized /by Deb Lovelace
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/in Uncategorized /by 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/in Get to Know Us /by Innovenn
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/in Uncategorized /by Innovenn
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 […]