Mr. Hugh MacNaught reports
VENTRIPOINT ANNOUNCES SUCCESSFUL COMPLETION OF ANNUAL QUALITY AND REGULATORY AUDITS
Ventripoint Diagnostics Ltd.
has completed its annual quality and regulatory audits covering the Medical Device Single Audit Program (MDSAP), ISO 13485:2016 quality management system and the European Union Medical Device Regulation (MDR 2017/745).
The completion of the audits confirms the continued effectiveness of Ventripoint's quality management system and its conformity with the applicable quality and regulatory requirements governing the development and manufacture of its medical devices in key international markets that are regulatory approved/cleared.
The successful audits are particularly relevant as Ventripoint continues to advance the commercialization of its VMS+ cardiac imaging platform and expand its activities across multiple markets. Maintaining these certifications provides an important foundation for ongoing product development, manufacturing and international market access.
The scope of the audits included:
- Medical Device Single Audit Program (MDSAP) -- MDSAP provides a common framework for assessing compliance with medical device regulatory requirements in participating jurisdictions, including the United States and Canada. Successful completion supports Ventripoint's ability to maintain its regulatory standing across these important markets through a coordinated audit process.
- ISO 13485:2016
-- This internationally recognized standard establishes requirements for quality management systems applicable to medical device manufacturers. Ventripoint's successful audit confirms the continued operation of a quality system designed to support consistent product performance, safety and manufacturing quality.
- EU Medical Device Regulation (MDR 2017/745)
-- Completion of the MDR surveillance audit supports Ventripoint's continued conformity with applicable EU Regulation 2017/745, including requirements relating to safety, performance, traceability and postmarket surveillance.
"We are pleased with the successful completion of these audits, which provide further confirmation of the strength and maturity of Ventripoint's quality and manufacturing processes," said Hugh MacNaught, president and chief executive officer of Ventripoint. "The successful TUV manufacturing audit completed in August, together with this latest review of our quality management system,
demonstrates that our processes are supporting both the continued development of VMS+ 4.0 and the requirements of an expanding commercial business. Maintaining rigorous quality standards across product design and development, manufacturing, production and software validation, and regulatory compliancem is essential as we increase adoption of VMS+ and expand into additional markets."
About Ventripoint Diagnostics Ltd.
Ventripoint
is an industry leader in the application of 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.
We seek Safe Harbor.
© 2026 Canjex Publishing Ltd. All rights reserved.