- OTCPINK:CMXC
- April 28, 2024
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Cell MedX Corp. is a research and development company publicly traded on the OTC Markets under the symbol CMXC. The Company is focused on the discovery, design, development, manufacture and commercialization of clinical therapeutic and wellness products for individuals who want more control over managing their health and general wellness.
Cell MedX is committed to individuals managing their well-being through the use of microcurrent therapeutic technology. The eBalance® is a compact, safe and easy-to-use microcurrent device. Cell MedX is committed to advancing research in the use of eBalance® technology through therapeutic device development, safety testing and observational clinical studies. The observational clinical studies were administered by a third party and authorized by Health Canada.
The studies were completed in 2017, with the completed eBalance® Clinical Report received in January 2018. These findings show encouraging results which confirm safety and areas of individual-reported therapeutic benefit that warrant further investigation. Once Cell MedX has received a Class II Medical Device designation in both Canada & the USA, Cell MedX plans to begin additional R&D observational clinical studies including the eBalance® Experience Study which conforms to the standards of the Canadian Tri-Council Research Ethics Guidelines
In December of 2018, Cell MedX received a Certificate of Conformity as a Class A (Professional Use Device) and a Class B (Home Use Device) from LabTest Certification Inc. To qualify the device LabTest used CSA, CE and UL standards for electrical safety and emission. Additionally, Cell MedX holds a CE Certificate of Conformity #16315-1E under Directive 93/42/EEC – Medical Device Directive; Standard IEC/EN 60601-1-2:2015.
In February 2020, BSI Group Canada Inc. completed a Medical Device Single Audit Program (“MDSAP”) Stage 2 audit of the Company’s quality management systems to confirm that the Company’s standard operating procedures and management systems conform to the ISO 13485:2016 and Canada Medical Devices Regulations – SOR 98/282; USA – 21 CFR 820; 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D.
In June 2020, the Company received the results of the audit. Cell MedX (Canada) Corp., the wholly-owned Canadian subsidiary, received MDSAP Certificate #716274, registered and made effective June 2, 2020.
In addition to the MDSAP certification, the Company met the requirements of ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes International Organization for Standardization (ISO) standard.
Cell MedX was issued ISO 13485:2016 Certificate #FM 716345, confirming Cell MedX operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the “Design, Development, and Manufacture of Microcurrent Therapeutic Devices.”