Vancouver, British Columbia--(Newsfile Corp. - November 29, 2021) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), 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."
About QMS and Regulatory Requirements
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.
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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.
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