Verisante Obtains Iso Certification of Quality Management System for Medical Device Manufacturing
(firmenpresse) - VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 07/28/11 -- (TSX VENTURE: VRS)(OTCQX: VRSEF)(PINK SHEETS: VRSEF)(FRANKFURT: V3T) (the "Company" or "Verisante"), a leader in cancer imaging technology, announced today that it has successfully completed the certification process for ISO 13485:2003, an internationally recognized quality management standard. The certification is a confirmation of the Company's ability to design and manufacture medical devices.
Verisante's quality management system was audited and assessed by BSI Group ("BSI"), one of the world's leading certification bodies, with more than 60,000 certified locations and clients in over 100 countries. BSI is a recognized registrar under the Canadian Medical Devices Conformity Scheme, designated as a Notified Body under the Medical Devices Directive for Europe, and designated as a Conformity Assessment Body under the Mutual Recognition Agreement between the European Union and Australia.
"We have achieved a very significant regulatory milestone on our pathway to the commercialization of ," said President and CEO Thomas Braun. "ISO Certification as a medical device manufacturer means our customers can be confident about the quality of our products and processes. It is a major hurdle in the requirements for obtaining regulatory approval of Verisante Aura™ in Canada, Europe and Australia. We continue to be on track to obtain Health Canada approval to begin sales and marketing efforts by the end of the year."
In conjunction with meeting the Canadian regulatory milestones, the Company also continues to prepare to obtain a CE Mark for both European and Australian regulatory approvals this year. Verisante has engaged Emergo Group, Inc. as its authorized representative in Europe to act as the point of contact for inspection authorities and to assist in device registrations and reporting. Emergo Group is a leading medical device consultancy with expertise in regulatory affairs, quality system compliance, clinical trial consulting, in-country representation and medical device distribution.
is a non-invasive device that uses proprietary technology to assist a medical professional in detecting skin cancer instantly, providing immediate and accurate results.
About Verisante Technology, Inc.
committed to . The and the utilize a proprietary cancer detection platform while the operating software and probe technology are unique to each device. The cancer detection platform was developed by the BC Cancer Agency and tested and refined on approximately 1,000 lesions at the Skin Care Centre at Vancouver General Hospital. This exclusive platform technology allows Verisante to develop and offer a range of compact, for many of the most common cancers. The Aura and Core have not yet been approved for sale. The Company anticipates Health Canada approval for the Aura in late 2011.
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Forward Looking Statements
This release contains forward-looking statements, including, but not limited to, statements regarding the future commercialization of medical devices, the market demand for these products and the proprietary protections the Company will obtain with regard to the technology, all of which statements are subject to market risks, and the possibility that the Company will not be able to obtain patent protection or obtain sufficient customer demand. These statements are made based upon current expectations and actual results may differ from those projected due to a number of risks and uncertainties.
The TSX Venture Exchange has neither approved nor disapproved of the contents of this press release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Contacts:
Verisante Technology, Inc.
Thomas Braun
President & CEO
(604) 605-0507
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Datum: 28.07.2011 - 08:00 Uhr
Sprache: Deutsch
News-ID 1025456
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Hospitals, Facilities and Providers
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