What You Should Know About the FDA Q-Sub Process

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.      

How Does Innovenn Improve Patient Outcomes?

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 […]

How the EU MDR Could Impact Medical Devices Sold in Europe

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 […]

Innovenn Testing Aids in Novel Technology Development

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 […]

ASN Kidney Week Abstract

Our CEO, Mary Dixon, and Director of Medical Device and Digital Innovation, Annie Lutz, co-authored an abstract titled “A Convolutional Neural Network for Large-Scale Segmentation of Kidneys in Autosomal Dominant Polycystic Kidney Disease” which was submitted and accepted to the American Society of Nephrology’s Kidney Week Conference. Read the full abstract on the ASN website, and […]

What is it like to participate in a study?

Clinical trials are a key part of the foundation for creating life-saving advancements in health care that depend on the participation of volunteers from all walks of life. You may be a perfectly healthy person or someone battling cancer, but your participation in research is vital to new discoveries.

Finding a clinical trial can be a daunting task

Here’s the reality: there are more than 200,000 clinical trials registered on the United States National Institutes of Health (NIH) clinical trials website throughout the United States and 191 countries.

Rare disease apps need a boost

For people with rare diseases, there are far fewer applications for iPhones or Android-based mobile devices than those with the most common diseases, according to a 2013 study by Borja Martinez-Perez of the University of Valladolid, Spain, published in the Journal of Medical Internet Research, and simple web searches for internet apps.