Ventripoint's Canadian Developement and Manufacturing Centre achieves ISO 13485 Registration
Toronto, Canada – June 24, 2016 - Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”) (TSXV:VPT) announces that it has successfully achieved ISO 13485 registration for the manufacturing and development centre in Toronto, Canada. This is a positive assessment of the Company’s quality management system and is a milestone in Ventripoint’s history, as it now allows the manufacture and design of VMS™ devices in Canada.
“I congratulate our new Canadian team for the successful completion of the ISO audit,” stated Dr. George Adams, President and CEO of Ventripoint. “We can now finalize the design of the VMS-PLUS heart analysis system, which was recently showcased at the annual congress of the American Society for Echocardiography in Seattle.”
Ventripoint achieved the certification from a third-party registrar, Intertek Testing Services NA, Ltd, reaffirming the Company’s commitment to quality products, customer service and continuous improvement. This allows us to maintain a solid foundation for regulatory approvals of our medical devices on a global basis.
ISO 13485:2003 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Chinese Partnership for Development, Manufacturing and Distribution
The Joint Venture in China is in the final stages of formation, incorporation and capitalization. A 48,000 sq. ft. office and manufacturing facility has been secured. The facility is located in a development zone in the city of Ma’anshan in Anhui Province.
“While the formal establishment of the partnership in China has taken longer than anticipated, the project has had continuous advancement and we can see the light at the end of the tunnel,” stated Dr. George Adams. “The Chinese market is ready for the improvements to cardiac diagnosis that the VMS provides and we will soon be ready to enter this market with a domestic manufacturing and distribution centre.”
Communications and infrastructure improvements to the facility are currently underway. The facility will include a state-of-the-art, 32,000 sq. ft. manufacturing centre and a 16,000 sq. ft. development and demonstration centre. Design of the manufacturing centre is complete and orders for manufacturing equipment will be placed shortly. Preparations are also under way for ISO, FDA and GMP certification of the manufacturing centre. Key staff are already in place and additional hiring will proceed over the next few months.
FORWARD LOOKING STATEMENT:
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