ChroMedX Appoints Michaela Shaw as Director of Quality Assurance and Regulatory Assurance
April 13, 2018 – ChroMedX Corp. (the “Company”) (CSE: CHX, OTC: CHXIF, Frankfurt: EIY2), developer of the HemoPalm Handheld Blood Analyzer Platform, is pleased to announce the appointment of Michaela Shaw as Director of Quality Assurance and Regulatory Assurance.
As Director of QA/RA Ms. Shaw’s immediate mandate is to accelerate the Company’s QMS towards ISO 13485 compliance by Q2 2019, as the Company expands its team, scope, and projects.
“I have worked with Michaela for several years in her role as Director of Regulatory affairs at Kangaroo and have always enjoyed her depth and style of execution” said Lahav Gil, CEO & Director, ChroMedX Corp. “Michaela brings a crisp leadership style and vast experience to ChroMedX, and I’m looking forward to seeing the evolution of our ISO 13485 QMS under her leadership.”
Michaela brings over 15 years experience within the medical device industry where she worked with a variety of start-up companies, leading them through the FDA, Health Canada and EU regulatory approval process. Michaela’s experience includes many noteworthy product and device regulatory approvals in the area of medical imaging, cardiovascular and respiratory therapy, medical device software and point-of-care diagnostic devices.
Michaela said of the appointment “I’m delighted and honoured to join the ChroMedX team and to have the opportunity to work with Lahav again. I look forward to developing and leading the regulatory and quality efforts for ChroMedX to ensure a speedy and successful regulatory market approval process.”
Michaela has provided quality and regulatory assistance to a variety of companies within the IVD, Medical Device, consumer and electronics industries. Previously, she has served as the Quality and Regulatory lead at Kangaroo Design, Thornhill Research Inc. and Z-Tech Canada Inc., where she led these innovative medical device firms through their initial ISO 13485 registration process and obtained EU, FDA and Health Canada approvals for their products. She is a member of the American Society of Quality (ASQ) where she achieved a Certified Manager of Quality (CQM) certification in 2011 and actively maintains her ASQ Certified Biomedical Auditor (CBA) certification.
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About ChroMedX Corp.
ChroMedX Corp. is a medical technology company focused on the development of novel, handheld medical devices for diagnostic testing at the patient’s bedside.
HemoPalm, the Company’s lead product is the only handheld blood analysis system which combines Blood Gases & Electrolytes with full CO-oximetry. It has a single-use cartridge/handheld reader format, providing the simplest, most rapid and accurate testing process for use in management of critical care patients. Current blood gas systems require purchase of a second device to carry out CO-oximetry measurements. In addition, HemoPalm has the ability to draw capillary blood directly from pin-prick sites into the cartridge, in addition to the commonly required, risk-associated arterial blood draws.
ChroMedX Corp. technologies are protected by the Company’s issued and pending patents, covering blood/plasma/serum collection, and processing and analysis.
W. Clark Kent
President & Director
Office. 647-872-9982 ext. 2
TF. 1-844-247-6633 ext. 2
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Except for statements of historic fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. The Company undertakes no obligation to update forward-looking information if circumstances or management's estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which filings are available at www.sedar.com