20:10:37 EST Mon 04 Nov 2024
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Ventripoint Diagnostics Ltd (2)
Symbol VPT
Shares Issued 158,601,905
Close 2024-10-07 C$ 0.18
Market Cap C$ 28,548,343
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Ventripoint Diagnostics completes three quality audits

2024-10-08 15:52 ET - News Release

Mr. Hugh MacNaught reports

VENTRIPOINT ANNOUNCES SUCCESSFUL COMPLETION OF KEY QUALITY AUDITS

Ventripoint Diagnostics Ltd. has completed three important quality audits, which were required to continue sales of the existing VMS+ models as well as to submit the newest version, VMS+4.0, for European Union review. All audits resulted in positive outcomes and demonstrated the company's commitment to upholding the highest standards in quality, safety and regulatory compliance. The audits were conducted by third party auditing organizations and addressed the following.

MDSAP (medical device single audit process)

The MDSAP audit insures compliance with the medical device regulatory requirements of multiple jurisdictions, including the United States and Canada. This program streamlines the regulatory process, allowing Ventripoint to maintain certifications across these key markets efficiently.

ISO 13485:2016 certification

ISO 13485:2016 is the globally recognized standard for quality management systems specific to the medical device industry. Passing this audit validates its comprehensive quality system, ensuring consistent performance, safety and product quality.

MDR 2017/745

The successful audit under the European Union's MDR 2017/745 demonstrates that Ventripoint's products meet the rigorous new regulatory standards governing medical devices in the European market. This regulation focuses on patient safety, product traceability and postmarket surveillance, ensuring a high level of safety and performance for all medical devices sold in Europe.

"These milestone achievements demonstrate Ventripoint's dedication to maintaining a robust quality management system and ensuring that its products meet the stringent requirements for medical devices of key international regulatory bodies. They are an important step as we position the company for growth," said Ventripoint president and chief executive officer Hugh MacNaught. "We believe that the advancements incorporated into VMS+4.0 improve the attractiveness of the technology and our team has worked to ensure that our processes will enable our ability to meet increased demand in Q4 and beyond."

About Ventripoint Diagnostics Ltd.

Ventripoint is an industry leader in the application of AI (artificial intelligence) to echocardiography. Ventripoint's VMS products are powered by its proprietary knowledge-based reconstruction 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.

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