ChroMedX Corp. (the “Company”) (CSE: CHX, OTC: CHXIF, Frankfurt: EIY2), developer of the HemoPalm Handheld Blood Analyzer System, is pleased to announce the engagement of Ants Kahu & Associates to implement Quality Management Systems to meet FDA and ISO requirements.
ChroMedX Corp. (the “Company”) (CSE:CHX, OTC: CHXIF, Frankfurt: EIY2), developer of the HemoPalm Handheld Blood Analyzer System, is pleased to announce the engagement of Ants Kahu & Associates to implement Quality Management Systems to meet FDA and ISO requirements.
Ants Kahu & Associates will work closely with ChroMedX to develop and implement the FDA Quality System Requirements (QSR) 21 CFR Part 820 and ISO 13485:2016. These Quality Management Systems are mandatory for any company developing and manufacturing medical devices. These requirements are meant to ensure that medical devices are safe, effective, and in compliance with the regulatory body of the country the device is to be sold in.
“We are very pleased to have Ants Kahu & Associates working with us on developing and implementing ChroMedX’s Quality Management System. I’ve personally worked with Ants in the past to setup, implement and manage quality systems to meet the requirements of both the FDA and ISO. Mr. Kahu has vast experience in implementing and training staff in Quality Management Systems and we look forward to using his expertise in setting up the ChroMedX quality system.” said Ash Kaushal, President & CEO, ChroMedX Corp.
The ChroMedX development team is currently working on the manufacturability and testing of the HemoPalm Biosensor and Cartridge components and continues to refine the analyzer design. Manufacturability and testing is a critical phase of the HemoPalm development. This phase is to ensure that proper materials and processes are defined for mass production of the consumable components.
About Ants Kahu & Associates.
Ants Kahu is a consultant and trainer specializing in productivity improvement. He uses his 16-Week Implementation Process to assist organization in implementing quality (ISO 9001/13485), health and safety (OHSAS 18001) and environmental (ISO 14001) management systems. An Engineering graduate of the University of Toronto, Ants has worked in process and systems engineering, sales, marketing management, operations management and general management.
Ants Kahu’s consulting and teaching practice for both service and manufacturing clients is firmly based on the thinking and writings of Vilfredo Pareto (The 80/20 Principle), James P. Womack (Lean Thinking) and Taichi Ohno (The Toyota Production System). To ensure that all productivity improvement initiatives deliver profit improvement, he believes in following the ‘money trail’ as demonstrated in the Six Sigma methodology. Ants Kahu is not tied to one methodology; he selects what is appropriate for each client assignment.
In addition to a clear and concise understanding of the relevant body of knowledge, his clients comment on his unique ability as a trainer to illustrate his material with real-world examples from his personal experience with a wide variety of public and private sector organizations. As a consultant, trainer and coach, Ants Kahu has worked with staff and management teams from over 300 organizations.
About ChroMedX Corp.
ChroMedX Corp. is a medical technology company focused on the development of novel medical devices for in vitro diagnostics and point-of-care testing. The devices are protected by the Company’s issued and pending patents, dealing with blood collection, analysis and plasma/serum processing.
The HemoPalm Handheld Blood Analyzer System is the only handheld blood analysis technology which combines Blood Gases & Electrolytes with full CO-oximetry. Currently this combination is not available on any of the handheld analyzers on the market. Existing technologies require users to purchase a second device to carry out the CO-oximetry. The Company’s technology has the advantage of being able to offer a single handheld blood analyzer that provides all the required tests for Blood Gases & Electrolytes, with full CO-oximetry and bilirubin. Another competitive advantage of the HemoPalm system will be its ability to draw capillary blood directly from a pin-prick site into the cartridge, providing an alternative to arterial blood. Drawing arterial blood is painful and can cause nerve damage. CO-oximetry is the measurement of five different hemoglobin species in blood.
The global market for Blood Gases & Electrolytes was estimated to be 1.5 Billion $US in 2015 and is projected to reach over 1.8 Billion by 2020.
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