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E-Zassi Introduces Online US FDA Regulatory Calculator – Medical Device Assessment

Posted Oct 20 2009 10:02pm

E-Zassi has rolled out a standalone module of their InnoVision software – the US Regulatory Calculator. This new tool allows a user to generate a image report in less than 10 minutes that documents a potential predicate FDA regulation no., product code and the classification & regulatory pathway associated for a medical technology.   Back in May I had the opportunity to speak with e-Zassi CEO Peter M. von Dyck. 

e-Zassi Marries Innovation and Collaboration in the Medical Device Industry – Interview with Peter Von Dyck

From the Interview:

“I had the pleasure to speak with the guys over ate-Zassirecently. Bringing a medical device to market is very costly and time intensive process to properly vet. The e-Zassi team has a lot of experience bringing medical devices to market and they thought there must be a better way. So, these guys decided to assist fellow innovators and bring efficiency to the $40+ billon business of medical technology innovation.

If you are a device manufacturer looking to collaborate, this could be the place to cut the search time down for prospective partners, or if you are a software vendor looking to collaborate with a device company the same would hold true. Anyone who reads this blog often enough knows there’s plenty of software and device information floating around.

The company is led by CEO Peter Von Dyck, who has about 30 patents to his credit. His vision was a platform that would bring together the latest trends in business intelligence software, Web 2.0 tools, online business networks and B2B communities. The result, after a lot of hard work, is e-Zassi.”

LifeScience Alley(R) Names e-Zassi Software As Preferred Provider for Networking and Decision Support for Medical Devices

During the interview we did a walk through of the software and it was easy enough for me to work with, not being a scientist, to do some sample cases and find the relative information.   Again, with the new software as a service tool, if you are developing medical devices, the InnoVision Software to project some of the information needed for the FDA could certainly save a ton of time.  BD 

Press Release:

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.

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“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

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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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