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 […]
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 […]
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. […]
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.
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 […]
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 […]
Getting a medical device through the regulatory process can be complicated. In this edition of the Innovenn Minute, Adam Vepraskas, Director of Regulatory Operations, provides background on the FDA Q-Submission process and why it is beneficial.
At Innovenn, our team works tirelessly to help our clients develop solutions that improve patient care and create positive outcomes. Recently our President and CEO, Mary Dixon, sat down with The Development Exponent to share her experience as a business owner, innovator, scientist, and problem solver. Take a minute to listen to Mary’s answer to […]
Big changes are on the horizon for medical device manufacturers marketing products in Europe. On May 26, 2021, the transition from the existing European Medical Device Directive (MDD 93/42/EC) to the European Medical Device Regulation (EU MDR 2017/745) takes effect, leaving in its wake a host of regulatory and compliance questions and challenges for device […]
Usability can make an important difference for user adoption of software that is a medical device (SaMD). Our experts understand design inputs needed to develop safe and easy to use medical software. Check out this publication a “Human Factors Impact on the Development of Software as a Medical Device (SaMD): A Case Study Using the […]
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