Cell MedX Corp. Receives Quality Management System ISO 13485:2016 Certificate for the eBalance® Device
Carson City, Nevada, April 7, 2020, Cell MedX Corp. (OTCQB: CMXC, 9CX:MUN) (“Cell MedX” or the “Company”), an early development stage bio-tech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness, announced today that the Company received a Quality Management System – ISO 13485:2016 certification for the Company’s eBalance® device (the “Device”).
At the end of February 2020 BSI Group Canada Inc. completed a Stage 2 audit on the Company. The audit objective was to conduct a Medical Device Single Audit Program (“MDSAP”) Stage 2 assessment and ISO 13485:2016 certification assessment. For the ISO13485:2016 certification it was to verify that all of the requirements of ISO13485:2016 are effectively implemented within the management system. For the MDSAP Stage 2 it was to evaluate the effective implementation of ISO 13485:2016 including jurisdiction requirements covering;
- The effectiveness of the manufacturer’s Quality Management System (“QMS”) incorporating the applicable regulatory requirements;
- Product/process related technologies;
- Adequate product technical documentation in relation to relevant regulatory requirements; and
- The manufacturer’s ability to comply with these requirements.
The assessment report was finalized in mid March 2020 with a recommendation for certification upon final report review. On March 31, 2020, the Company received Certificate No. FM 716345, certifying that the Company operates a Quality Management System which complies with the requirements of ISO 13485:2016 for design, development and manufacture of microcurrent therapeutic devices for wellness and pain relief.
The Company anticipates receiving the MDSAP certification within the next 60 days, at which time the Company will be eligible to apply to Health Canada for a Class II Medical Device License.
The Company has also been in the process of completing its documentation and testing required for the 510(K) submission to the US FDA and expects to get an update on the progress within the next few weeks.
In addition, the Company wishes to announce that in order to support increased interest regarding the Company and its operations, the Company has engaged Larry Heuchert as an investors’ relations representative. The Company agreed to pay Mr. Heuchert $2,000 per month over the next 12 months and issue Mr. Heuchert 100,000 shares of the Company’s common stock.
Frank McEnulty, the Company’s CEO and Director, stated, “We are very pleased to receive the ISO 13485:2016 certification as this is a big step in our move towards Class II medical device classification of the eBalance® device”.
About Cell MedX Corp.
Cell MedX Corp. is a biotech company focused on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness and alleviate complications associated with medical conditions including, but not limited to: diabetes, Parkinson’s disease, high blood pressure, neuropathy and kidney function. The final report on the Observational Clinical Trials has been received by Health Canada. For more information about the Company and its technology please visit the Company’s website at www.cellmedx.com/investors/overview/. For the Company’s newsletter please visit www.cellmedx.com/media/newsletters/
On behalf of the Board of Directors of Cell MedX Corp.
Frank McEnulty
CEO, Director
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects”, “intends”, “estimates”, “projects”, “anticipates”, “believes”, “could”, and other similar words. All statements addressing product performance, events, or developments that the Company expects or anticipates will occur in the future are forward-looking statements. Because the statements are forward-looking, they should be evaluated in light of important risk factors and uncertainties, some of which are described in the Company’s Quarterly, and Annual Reports filed with the United States Securities and Exchange Commission (the “SEC”). Should one or more of these risks or uncertainties materialize, or should any of the Company’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Company’s forward-looking statements. In particular, the Company’s eBalance technology is still in development. Except as required by law, Cell MedX Corp. disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this press release. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements.
The information presented in this press release, including the statements made regarding the eBalance® device, have not been evaluated by the Food and Drug Administration or Health Canada, nor has it been peer reviewed. eBalance® should not be viewed as a substitute for professional medical advice, diagnosis, or treatment. No stock exchange, securities commission or other regulatory body has reviewed nor accepts responsibility for the adequacy or accuracy of this release. Investors are advised to carefully review the reports and documents that Cell MedX Corp. files from time to time with the SEC, including its Annual, Quarterly and Current Reports.
SOURCE:
Cell MedX Corp.
For further information visit: www.cellmedx.com.
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