Ventripoint Awarded MDSAP Certification, the Highest Quality Standards
in the Medical Device Industry
Toronto, January 22, 2019 – Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”, TSXV:VPT, OTCQB:VPTDF) is pleased to announce that it has successfully received the Medical Device Single Audit Program (MDSAP) certification, following an audit of its quality management system by our Notified Body/Registrar, an authorized third party auditing organization.
The Medical Device Single Audit Program (MDSAP) became a mandatory requirement by Health Canada on January 1, 2019 and allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions, including Canada, United States, Japan, Brazil, and Australia.
"We are very proud of this latest achievement, which solidifies Ventripoint’s abilities to continue to produce and sell its VMS+ System globally and positions us at the forefront of quality assurance," commented Dr. Alvira Macanovic, PhD, Ventripoint’s Director of Regulatory Affairs and Quality Assurance.
The MDSAP audit approach reduces the need for duplicate quality management audits, allowing device manufacturers to better manage costs and ease global market access.
About Ventripoint Diagnostics Ltd.
Ventripoint’s technology is a leading Artificial Intelligence (AI) approach known as Knowledge-Based Reconstruction (KBR), used to create applications to monitor heart disease, a leading cause of death worldwide. The VMS+ is the first cost-effective and accurate AI tool for measuring whole heart function using conventional ultrasound. The Company has developed a suite of applications for all major heart diseases and is actively commercializing the approach to improve cardiac care.
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Forward Looking Statements:
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