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The Perks of a Career at Innovenn
/in Get to Know Us /by bizzybizzyHistory of Innovenn Benefits When Innovenn was a start-up, we were unable to offer various benefits (other than PTO ) that might be available with larger companies. Our key benefit was being part of an exciting, growing, innovative industry, and a forward-thinking culture. The good news is that once we became profitable, our CEO made […]
Culture at Innovenn
/in Get to Know Us /by bizzybizzyInnovenn’s History Founded in 2013, Innovenn is a 100% women-owned small business with an over 50% female workforce. Innovenn, Inc., helps our client’s develop patient-centered, leading-edge, AI-enhanced, medical device software (SaMD). At the intersection of engineering and data science, Innovenn and our collaborators take deep learning into the real world to improve human health. We […]
Expert Design Control Services by Innovenn
/in Medical Device Development /by InnovennWhat 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 Medical Device Approval /by InnovennWhen 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 InnovennThe 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 InnovennWhen 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 LovelaceMADISON, 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 LovelaceAnnie 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 LovelaceWhen 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 LovelaceInnovenn’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 […]