Navigation Links
Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center

ANN ARBOR, Mich., Aug. 3 /PRNewswire/ -- 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), 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.

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.

For more information on VCI's latest innovations contact Dr. Norm Howe at howen at or 734 274 4680. For more information on MIC's service offerings, please contact Brenda Jones at brenjone at or (734) 998-6994.

SOURCE Validation and Compliance Institute, LLC
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. University of Nevada School of Medicine Professor Confirms Accuracy Through Validation Study Using the CSI Health Station Model 6K
2. Sutter Violating State Safety Laws on Assuring Proper Competency Validation of Strike Staff, Say RNs
3. Michael J. Fox Foundation Commits Up to $2 Million for PD Drug Development Under Target Validation 2008
4. UK Physicians Fear New Revalidation Procedures Will Reduce Morale, Decrease Time with Patients and Belittle GP Professionalism, According to New TNS Healthcare Research
5. Pathwork Diagnostics Collaborates With Guys and St Thomas on Tissue of Origin Test Validation in the UK
6. Webinar Alert: Coverity Announces Verification and Validation of Medical Device Software with Static Analysis - A Review of FDA Guidance and Best Practices
7. MDS Analytical Technologies Announces Validation of Two More Kits for High-Throughput Detection of Melamine in Food
8. Domino/Aronberg Prescription Drug Validation Plan Saves Lives, Protects Privacy, Costs Less
9. Pathwork Tissue of Origin Test Validation Study Published in Journal of Clinical Oncology
10. White Paper Explains Package Validation Requirements For Medical Devices & Combinatory Products
11. Validation & Compliance Institute, LLC, to Provide Dietary Supplement GMP Training for NSF International
Post Your Comments:
(Date:12/1/2015)... Middletown, PA (PRWEB) , ... December 01, 2015 ... ... separate environments; however, there are professionals who believe that with innovative technologies and ... services allows the patient to get the benefit of a dual-approach to his ...
(Date:12/1/2015)... ... 01, 2015 , ... CloudLIMS today announced that it is ... under the New Products and Services category for its innovative product offering, BioTracer. ... that helps labs organize data and track samples with storage inventories. BioTracer's ...
(Date:12/1/2015)... ... December 01, 2015 , ... The importance of volumetric ... the focus of numerous abstracts accepted for presentation here, at the 101st Annual ... abstracts highlight the use of Volpara Solutions’ quantitative breast imaging software tools for ...
(Date:12/1/2015)... ... December 01, 2015 , ... SAN ... today announced that the organization has awarded Education and Developmental Therapies (EDT), an ... Award. The award celebrates exceptional special needs providers that excel in synthesizing the ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... the care management and population health arenas, is pleased to announce that VIP ... containment services, has successfully implemented the ACUITY Complete Care™ Management to back their ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)...  The migration to value-based care will require ... that help patients stay healthy and reduce healthcare ... enabled, incorporate care guidelines and be reflective of ... also allow all stakeholders to collaborate across care ... That is the vision, however, research by Chilmark ...
(Date:12/1/2015)... -- --> --> ... (NKI-AVL), among the world,s largest and most prestigious ... Icon™, the company,s latest generation stereotactic radiosurgery system ... --> With the option to use ... Knife Icon offers greatly enhanced flexibility in how ...
(Date:12/1/2015)... , December 1, 2015 ... segments the concerned market with analysis and forecast of ... orthobiologics report defines and segments the concerned market with ... to the Market Research Report "North American Orthobiologics Market ... Factors & Spinal Stimulation, Stem Cell Therapy, Viscosupplementation), by ...
Breaking Medicine Technology: