Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center
Validation & Compliance Institute (VCI), is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by the US Food and Drug Administration (FDA) in order to market medical devices. The training will help innovators to make decisions early in their projects that will save them time and money when they submit applications to FDA.
One of the biggest cost drivers in the development of new medical devices is in gathering the data that proves safety and functionality of the new device to the satisfaction of FDA. These activities consume a great deal of calendar time as well, which can delay sales of the new device and availability to patients.
This time and money has a significant impact on the payback that investors might receive and therefore affects whether the project can attract funding.
Fortunately innovators have some latitude in their approach to the regulatory process. But those decisions are better made early in the project where the trajectory can be more easily adjusted.
The purpose of this series of videos is to help innovators to understand the kinds of questions they need to ask so that they can get answers early in their projects.
"This training asset will be critical to the MIC’s educational goal," said Brenda Jones, MIC's Managing Director. “We must provide an understanding of the critical early steps inventors should take to avoid rework and improve their chances of regulatory approval.”
Validation & Compliance Institute, LLC: Validation and Compliance Institute (VCI) www.vcillc.com, provides a full range of compliance services for FDA regulated industries. From submissions to process validation VCI can do the work for you, or train you to do it yourself. VCI writes INDs, IDEs, NDAs, 510Ks, PMAs, SOPs, and DMFs.
For more information on VCI's latest innovations contact Dr. Norm Howe at howen@vcillc.com or 734 274 4680. For more information on MIC's service offerings, please contact Brenda Jones at brenjone@umich.edu or (734) 998-6994.
About the University of Michigan Medical Innovation Center: Our mission is to foster innovation and enable new medical technologies by integrating clinicians, dentists, scientists, engineers, and business professionals through education and research to ultimately improve health.
