IZOZF - Izotropic Implements Quality Management System for IzoView Breast CT Device Manufacturing
(TheNewswire)
VANCOUVER, BC - TheNewswire - November 29,2021 - Izotropic Corporation (“ Izotropic ” or the “ Company ”) (C NSX : IZO. CN ) (OTC: IZOZF )(FSE: 1R3 ), a Company commercializing a dedicated breast CT (computed tomography)imaging platform, IzoView, for the more accurate detection anddiagnosis of breast cancers is pleased to announce that it hasimplemented a Quality Management System (QMS) for regulatory andmanufacturing purposes.
The QMS is a system of procedures and processescovering 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 componentof Izotropic’s plan to provide IzoView products that consistentlymeet both customer and applicable regulatory requirements.
In addition to being a requirement for submission formarket authorization, a QMS implemented during the product developmentphase can reduce the time to market between completion of developmentand market authorization. It also helps to mitigate the likelihood ofcostly and avoidable regulatory warning letters or product recalls inthe future. The QMS incorporates all parties involved in themanufacturing chain and provides controls for maintaining regulatorystandards as required.
By implementing a QMS during the initial IzoView devicebuild, the procedures and systems required to create and maintainIzoView products will follow a structured approach that can be scaledup to full stage production.
As part of the QMS, Izotropic has written specificprocesses and procedures for its recently announced radiation imaging subsystem thatwas powered on, tested, and formally certified as safe for use. Thesubsystem was designed, assembled, and tested under the QMS plan inorder to mitigate and reduce the risk of the subsystem not operatingwithin expected parameters, and will be used for building clinicalstudy units and then for full stage production manufacturing.
“The QMS is another milestone and a critical tool inIzoView’s final development, testing and manufacturing stages,”said Dr. John McGraw, CEO. “The elements of the QMS developed willbe efficiently rolled out on an as-needed basis in step with ourdevice completion schedule, initial clinical study, followed by fullstage production and the commercialization of IzoView.”
About QMS andRegulatory Requirements
A QMS is a submission requirement for marketauthorization in nearly all markets. The U.S. FDA requires medicaldevice manufacturers of Devices Class II and higher to have a QMS inplace that is compliant with the Code of Federal Regulations (CFR)prior to submission. All other markets require QMS to be compliant andcertified with ISO standards prior to submission.
ON BEHALF OF THE BOARD
For investor relations inquiries,contact:
James Berard
Email: jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1
About Izotropic Corporation
Izotropic Corporation is the only publicly tradedcompany commercializing a dedicated breast CT imaging platform,IzoView, for the more accurate detection and diagnosis of breastcancers. To expedite patient and provider access to IzoView,Izotropic’s initial clinical study intends to demonstrate superiorperformance of diagnostic breast CT imaging over diagnosticmammography procedures and will initiate in Q2 2022. In follow-onclinical studies, Izotropic intends to validate platform applicationsincluding breast screening in radiology, treatment planning andmonitoring in surgical oncology, and breast reconstruction and implantmonitoring in plastic and reconstructive surgery.
More information about Izotropic Corporation can befound on its website at izocorp.com and by reviewing itsprofile on SEDAR at sedar.com
Forward-Looking Statements
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