Izotropic Implements Quality Management System for IzoView Breast CT Device Manufacturing
VANCOUVER, BC - TheNewswire - November 29, 2021 - Izotropic Corporation (“Izotropic” or the “Company”) (CNSX:IZO.CN) (OTC:IZOZF) (FSE:1R3), a Company commercializing a dedicated breast CT (computed tomography) imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers is pleased to announce that it has implemented a Quality Management System (QMS) for regulatory and manufacturing purposes.
The QMS is a system of procedures and processes covering aspects of a product lifecycle from the design, manufacturing, supplier management, risk management, clinical data, product labeling, storage, distribution, to service and maintenance. As an evolving quality control system, the QMS is a critical component of Izotropic’s plan to provide IzoView products that consistently meet both customer and applicable regulatory requirements.
In addition to being a requirement for submission for market authorization, a QMS implemented during the product development phase can reduce the time to market between completion of development and market authorization. It also helps to mitigate the likelihood of costly and avoidable regulatory warning letters or product recalls in the future. The QMS incorporates all parties involved in the manufacturing chain and provides controls for maintaining regulatory standards as required.
By implementing a QMS during the initial IzoView device build, the procedures and systems required to create and maintain IzoView products will follow a structured approach that can be scaled up to full stage production.
As part of the QMS, Izotropic has written specific processes and procedures for its recently announced radiation imaging subsystem that was powered on, tested, and formally certified as safe for use. The subsystem was designed, assembled, and tested under the QMS plan in order to mitigate and reduce the risk of the subsystem not operating within expected parameters, and will be used for building clinical study units and then for full stage production manufacturing.
“The QMS is another milestone and a critical tool in IzoView’s final development, testing and manufacturing stages,” said Dr. John McGraw, CEO. “The elements of the QMS developed will be efficiently rolled out on an as-needed basis in step with our device completion schedule, initial clinical study, followed by full stage production and the commercialization of IzoView.”
A QMS is a submission requirement for market authorization in nearly all markets. The U.S. FDA requires medical device manufacturers of Devices Class II and higher to have a QMS in place that is compliant with the Code of Federal Regulations (CFR) prior to submission. All other markets require QMS to be compliant and certified with ISO standards prior to submission.
ON BEHALF OF THE BOARD
For investor relations inquiries, contact:
Toll Free: 1-833-IZOCORP ext.1
About Izotropic Corporation
Izotropic Corporation is the only publicly traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic’s initial clinical study intends to demonstrate superior performance of diagnostic breast CT imaging over diagnostic mammography procedures and will initiate in Q2 2022. In follow-on clinical studies, Izotropic intends to validate platform applications including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery.
This document may contain statements that are “Forward-Looking Statements,” which are based upon the current estimates, assumptions, projections and expectations of the Company’s management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These statements are not guarantees of performance and involve risks and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company’s activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind.
Copyright (c) 2021 TheNewswire - All rights reserved.