VPTDF - Ventripoint Successfully Renews QMS Certification
(TheNewswire)
Toronto, Ontario - The Newswire -December 2 9 2021 - VentripointDiagnostics Ltd. (" Ventripoint " or the " Company "),(TSXV:VPT ) ( OTC:VPTDF) ispleased to announce that is it has successfully completed the MedicalDevice Single Audit Program (MDSAP) re-certification for its QualityManagement System (QMS) under ISO 13485:2016 regulations and the FDAQuality System Regulations, which facilitates continued design,manufacturing, installation and servicing of its products in Canadaand the United States.
“Ventripoint is committed to maintaining completecompliance with the required standards and regulations for ensuringthe highest quality products,” stated Dr. Alvira Macanovic,Vice-President of Ventripoint.
The Company has had its MDSAP certification since 2018and underwent a 2.5-day audit at its corporate offices andmanufacturing facility under the MDSAP as part of its three-yearre-certification audit. The Company had no findings. The newcertificate was issued December 25, 2021, and is in effect for thenext 3 years, subject to annual surveillanceaudits .
The MDSAP is a program that facilitates the singleregulatory audit of a medical device manufacturer’s QMS andsatisfies the requirements of multiple regulatory jurisdictions,namely Canada and the United States. The recertification auditensures that Ventripoint’s QMS continues to be suitable and able tomeet QMS requirements under the MDSAP, including the internationalstandard ISO 13485:2016, as well as the requirements set forth by theUnited States Quality System Regulations.
About Ventripoint DiagnosticsLtd.
Ventripoint has become anindustry leader in the application of AI (Artificial Intelligence) toechocardiography. Ventripoint's VMS products are powered by itsproprietary KBR technology, which is the result of a decade ofdevelopment and provides accurate volumetric cardiac measurementsequivalent to MRI. This affordable, gold-standard alternative allowscardiologists greater confidence in the management of their patients.Providing better care to patients serves as a springboard and basicstandard for all of Ventripoint's products that guide our futuredevelopments. In addition, VMS+ is versatile and can be used with allultrasound systems from any vendor supported by regulatory marketapprovals in the U.S., Europe and Canada.
For further information, pleasecontact:
Dr. Alvira Macanovic
(416) 848-4156?
Neither the TSX Venture Exchange nor its RegulationServices Provider (as that term is defined in the policies of the TSXVenture Exchange) accepts responsibility for the adequacy or accuracyof this news release.
Forward Looking Statements
This news release contains forward-looking statementsand forward-looking information within the meaning of applicablesecurities laws. The use of any of the words "expect","anticipate", "continue", "estimate","objective", "ongoing", "may","will", "project", "should","believe", "plans", "intends'' and similarexpressions are intended to identify forward-looking information orstatements. The forward-looking statements and information are basedon certain key expectations and assumptions made by the Company.Although the Company believes that the expectations and assumptions onwhich such forward-looking statements and information are based arereasonable, undue reliance should not be placed on the forward-lookingstatements and information because the Company can give no assurancethat they will prove to be correct.
Since forward-looking statements and informationaddress future events and conditions, by their very nature theyinvolve inherent risks and uncertainties. Actual results could differmaterially from those currently anticipated due to a number of factorsand risks. Factors which could materially affect such forward-lookinginformation are described in the risk factors in the Company's mostrecent annual management's discussion and analysis that is availableon the Company's profile on SEDAR at www.sedar.com. Readers arecautioned that the foregoing list of factors is not exhaustive. Theforward-looking statements included in this news release are expresslyqualified by this cautionary statement. The forward-looking statementsand information contained in this news release are made as of the datehereof and the Company undertakes no obligation to update publicly orrevise any forward-looking statements or information, whether as aresult of new information, future events or otherwise, unless sorequired by applicable securities laws.
Copyright (c) 2021 TheNewswire - All rights reserved.