Posts by ViaTechMD, LLC

In June of 2018, ViaTechMD engaged DuVal & Associates to assist in FDA negotiations and development of a risk and mitigation analysis and clinical trial design as requested by the FDA. DuVal & Associates was formed in 2004 with a mission to focus on serving companies with unique needs that are regulated by the FDA,…

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In collaboration with Baylor College of Medicine, Christus Santa Rosa Health System and Children’s Hospital of San Antonio, ViaTechMD is undertaking a second human fitment study under IRB approval FDA guidelines. This comes ahead of our second FDA Pre-submission Filing, which will include a sophisticated clinical trial proposal being designed in collaboration with regulatory experts…

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ViaTechMD has contracted Freudenberg Medical, to provide polymer engineering, manufacturing, assembly, packaging, testing and quality control services to our venture. With 11 locations worldwide, Freudenberg Medical is part of the Freudenberg Group. Founded over 165 years ago, the company develops innovative products and services for more than 30 market segments worldwide, and serves 43 of the 50…

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ViaTechMD has contracted and is in collaboration with Emergo’s senior-level experts in regulatory pathway and market entry strategy, risk management, device classification and registration, quality management system compliance, and clinical evaluation reports. Emergo, a UL company, has become a leading consultancy organization with more than 2,800 medical device and IVD clients worldwide. The company maintains…

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Along with our initial human fitment Study Team, including Dr. Phyllis D. Marx (Principal Investigator), Dr. William E. Gannon, Jr. (Medical Monitor), and our CRO Teams at Stiris Research and Radiant Research, ViaTechMD has just completed a series of very successful patient fitment, comfort and organ interaction trials.

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