Fremont, CA, 2016-Jul-25 — /EPR Network/ — NetZealous LLC, a professional trainings provider in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings to make the process of getting organizations’ 510 (k) right. These trainings help manufacturers of medical devices and in-vitro diagnostics, as well as those involved in the various levels of the 510 (k), such as R&D, development, quality assurance and quality control, production, operations, engineering, compliance, and regulatory affairs and all levels of management understand ways by which they can develop what may be called a bulletproof 510(k) submission.
The 510 (k) is a premarket submission that a manufacturer of a medical device has to make to the FDA to show that the device it intends to market is at least as safe and effective as a legally marketed device that is not subject to PMA. In other words, the 510 (k) must demonstrate that it has what is termed as Substantial Equivalence (SE).
“Complete understanding of the entire 510 (k) is what professional trainings from NetZealous LLC impart. Our experts have gained a lot of experience working in the industry for many years. They understand the complete details of 510 (k), which they pass on to the participants. As a result of the learning gained at our trainings; medical device, in-vitro and other professionals can understand how to do the right things to get their 510 (k) right. This is very important, as an organization that fails at its 510 (k) can face a lot of issues. Through our trainings, we want to ensure that such things do not happen”, said Satisha Naraharimurthy, Founder and CEO of NetZealous LLC.
Adding to this, Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous LLC, says: “NetZealous LLC’s trainings cover all aspects of all the three types of Premarket Notification 510(k)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. These trainings help participants understand the aspects of product modifications that could significantly affect safety and effectiveness while being subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. The aim is to help them take critical decisions on getting their medical devices approved”.
Liju Mathew, Co-Founder and Chief Business Development at NetZealous LLC says, “Where NetZealous LLC’s professional trainings stand out is in the relevance and suitability of its trainings for the intended audience. Our courses on 510 (k) cover not only 510 (k), but also who is required to submit it, where to do so and what to expect post submission, when it is required and when it is not, what exemptions medical devices have to the submission processes and what special considerations they might expect, what the De Novo process of submission means, and many other aspects of a 510 (k) submission. So, NetZealous LLC’s trainings are well rounded and easy to comprehend”.