Tuesday, October 20, 2009

Medical Device Technology Assessment

Here's a very interesting press release I'd like to share:

e-Zassi.com  provides Industry with  Online U.S. FDA Regulatory Calculator
for Rapid Medical Device Technology Assessment 

High-powered tool now available to non members for introductory rate that includes one-year membership ­

FERNANDINA BEACH, Florida, Oct. 20, 2009 – e-Zassi.com, the fast-growing provider of the medical device industry’s first secure online decision-support and industry network, has released its powerful U.S. Regulatory Calculator as a stand-alone tool available at $375 at www.e-Zassi.com to give users an analysis of the FDA classification of up to three separate medical technologies along with a one-year membership in the e-Zassi medical device industry network.

e-Zassi.com was developed as an online industry network to allow everyone across the spectrum of medical device industry to search, match, collaborate and analyze technologies, individuals and organizations using the most advanced decision-support search engine platform that uniquely fosters deeper levels of information sharing while also protecting members from over-disclosure issues that could negatively impact intellectual properties.

The e-Zassi.com U.S. Regulatory Calculator
The e-Zassi.com U.S. Regulatory Calculator is proprietary software powered by a current database of information on classified medical devices.  Anyone involved with medical devices – from researchers to engineers, technology transfer agents, business development officers, medical device companies and investors – can use the new FDA Regulatory Calculator by inputting non-confidential product attributes and physical details about their new product or technology.  The e-Zassi.com U.S. Regulatory Calculator searches and provides the potential predicate codes and other critical regulatory information in just minutes, rather than more than two months, which is often how long it takes for the U.S. Food and Drug Administration to determine a product’s classification.
“Because many products don’t fit neatly into existing classifications, this process is often a complex and confusing first step when designing a product or making a submission to the FDA,” said e-Zassi Chief Executive Officer Peter M. von Dyck, who holds numerous patents and has commercialized many new medical device technologies.   Von Dyck explains that: “Not knowing the potential FDA classification early on can adversely skew the entire development, clinical trials, commercialization and capitalization plans.  Understanding and navigating the regulatory environment and classification that a newer medical technology will need to conform to is one of the most essential elements of any development and commercialization plan and without this information early and throughout the development process you are in essence developing in the dark.”
About e-Zassi.com
e-Zassi.com is a subscription-based online community and Software as a Service (SaaS) company that was spun off Zassi Medical Evolutions®, a privately held company with more than a decade innovating and developing in medical devices.  The full suite of software tools on e-Zassi.com supports those in the medical device industry, from product development through manufacturing and distribution.  Tools allow for technology transfer; business development; market and commercial analysis; due diligence & portfolio management; intellectual property and patent development; product development and financial planning; and capital acquisition via venture capital and grants. Customized memberships are available now. For more information regarding e-Zassi.com or to join the Network, please visit www.e-zassi.com or call +1.866.474.6328. 

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