Izotropic Implements Quality Management System For IzoView Breast Computed Tomography Device Manufacturing
Vancouver, British Columbia – (Newsfile Corp. – November 29, 2021) – Izotropic Company (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) (“Izotropic“or the”Society“), a company marketing a dedicated breast computed tomography (computed tomography) imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancer is pleased to announce that it has implemented a system Quality Management System (QMS) for regulatory and manufacturing purposes.
The QMS is a system of procedures and processes covering aspects of a product’s life cycle from design, manufacturing, supplier management, risk management, clinical data, product labeling, storage , distribution, service and maintenance. As an evolving quality control system, the QMS is an essential part of Izotropic’s plan to deliver IzoView products that consistently meet customer requirements and applicable regulatory requirements.
In addition to being a requirement for the submission of a marketing authorization, a quality management system implemented during the product development phase can reduce the time to market between completion development and marketing authorization. It also helps mitigate the likelihood of costly and preventable regulatory warning letters or product recalls in the future. The QMS integrates all parties involved in the manufacturing chain and provides controls to maintain regulatory standards as needed.
By implementing a quality management system during the initial construction of the IzoView device, the procedures and systems required to create and maintain IzoView products will follow a structured approach that can be extended to full production.
As part of the QMS, Izotropic has drafted specific processes and procedures for its recently announced X-ray imaging subsystem which has been powered up, tested and officially certified as safe to use. The subsystem has been designed, assembled and tested as part of the QMS plan to mitigate and reduce the risk that the subsystem will not perform within the expected parameters, and will be used for the construction of units. clinical studies, then for full-stage production manufacturing.
“The QMS is another milestone and an essential tool in the final stages of IzoView development, testing and manufacturing,” said Dr. John McGraw, CEO. “The developed quality management system elements will be deployed effectively as needed, in accordance with our device’s completion schedule, at the initial clinical study, followed by full-stage production and commercialization of IzoView.” . “
About the QMS and regulatory requirements
A QMS is a submission requirement for marketing authorization in almost all markets. The US FDA requires that manufacturers of Class II and higher medical devices have a quality management system in place that complies with the Code of Federal Regulations (CFR) prior to submission. All other contracts require the 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 to market a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancer. To accelerate patient and provider access to IzoView, the initial clinical study of Izotropic aims to demonstrate superior performance of diagnostic breast CT imaging compared to diagnostic mammography procedures and will begin in the second quarter of 2022. In follow-up clinical studies, Izotropic intends to validate platform applications, including breast cancer screening in radiology, planning and follow-up of oncologic surgery treatments, and breast reconstruction and follow-up. implant in plastic and reconstructive surgery.
More information on Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.
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