Navigation Links Provides Industry With Online U.S. FDA Regulatory Calculator for Rapid Medical Device Technology Assessment

FERNANDINA BEACH, Fla., Oct. 20 /PRNewswire/ --, 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 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. 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 U.S. Regulatory Calculator

The 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 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 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 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 or to join the Network, please visit or call +1.866.474.6328.


Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
2. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
3. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
4. Raptor Pharmaceuticals Provides Update of Product Programs
5. Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
6. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
7. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
8. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
9. Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
10. Treatment with PEGASYS(R)/COPEGUS(TM) Provides Hope for Hepatitis C Patients Whose Infection Did Not Initially Respond to Peg-Intron(R)/Ribavirin
11. Improved Cornea Surgery Technique Provides Enhanced Transplant Success
Post Your Comments:
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
(Date:9/19/2017)... 2017   ZirMed Inc ., a recognized leader in ... it has been ranked #1 by its users for the ... 2017 User Survey. ZirMed was recognized as the top-ranked end-to-end ... medical centers over 200 beds and holds one of the ... survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):