Ventripoint Successfully Renews QMS Certification
Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”), (TSXV:VPT; OTC:VPTDF) is pleased to announce that is it has successfully completed the Medical Device Single Audit Program (MDSAP)
re-certification for its Quality Management System (QMS) under ISO 13485:2016 regulations and the FDA Quality System Regulations, which facilitates continued design, manufacturing, installation and servicing of its products in Canada and the United States.
“Ventripoint is committed to maintaining complete compliance with the required standards and regulations for ensuring the highest quality products,” stated Dr. Alvira Macanovic, Vice-President of Ventripoint.
The Company has had its MDSAP certification since 2018 and underwent a 2.5-day audit at its corporate offices and manufacturing facility under the MDSAP as part of its three-year re-certification audit. The Company had no findings. The new certificate was issued December 25, 2021, and is in effect for the next 3 years, subject to annual surveillance audits.
The MDSAP is a program that facilitates the single regulatory audit of a medical device manufacturer’s QMS and satisfies the requirements of multiple regulatory jurisdictions, namely Canada and the United States. The recertification audit ensures that Ventripoint’s QMS continues to be suitable and able to meet QMS requirements under the MDSAP, including the international standard ISO 13485:2016, as well as the requirements set forth by the United States Quality System Regulations.
About Ventripoint Diagnostics Ltd.
Ventripoint has become an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint’s VMS products are powered by its proprietary KBR technology, which is the result of a decade of development and provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold-standard alternative allows cardiologists greater confidence in the management of their patients. Providing better care to patients serves as a springboard and basic standard for all of Ventripoint’s products that guide our future developments. In addition, VMS+ is versatile and can be used with all ultrasound systems from any vendor supported by regulatory market approvals in the U.S., Europe and Canada.
For further information, please contact:
Dr. Alvira Macanovic
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This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends” and similar expressions are intended to identify forward-looking information or statements. The forward-looking statements and information are based on certain key expectations and assumptions made by the Company. Although the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information because the Company can give no assurance that they will prove to be correct. Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Factors which could materially affect such forward-looking information are described in the risk factors in the Company’s most recent annual management’s discussion and analysis that is available on the Company’s profile on SEDAR at www.sedar.com.
Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Factors which could materially affect such forward-looking information are described in the risk factors in the Company’s most recent annual management’s discussion and analysis that is available on the Company’s profile on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements included in this news release are expressly qualified by this cautionary statement. The forward-looking statements and information contained in this news release are made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.