Navigation Links
Solos Endoscopy and TUV SUD America Schedule Stage 2 ISO 13485 Audit for August 16, 2013
Date:6/12/2013

BOSTON, June 12, 2013 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company and TUV SUD America has scheduled its Stage 2 ISO 13485 Audit for August 16, 2013.

Solos Endoscopy completed the Stage 1 Audit with TUV SUD America on Tuesday, February 26, 2013. Solos Endoscopy's Quality Manual and 28 Quality System Procedures were reviewed by TUV SUD for compliance to the international quality system standard ISO 13485:2003, to the European Union's Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).

Solos Endoscopy will work with consulting company Expert Resource to correct any non-conformities found during the Stage 1 Audit in preparation for the Stage 2 Audit with TUV SUD. Solos Endoscopy has six months from the Stage 1 Audit to schedule the Stage 2 Audit. Successful completion of the Stage 2 Audit will result in Solos Endoscopy being certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003 will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the MammoView® in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView® product line in Canada.

TUV SUD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to the ISO 13485 standard. TUV SUD also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TUV SUD is a Notified Body for certification to all relevant EU Directives. With this complete service package, TUV SUD can assist medical companies in accessing markets nationally, in Europe, and globally. Solos Endoscopy has posted on its website an updated schedule as of January 2013. 

Expert Resource will attend the final audit, and help interpret any findings.  Solos Endoscopy joins a high profile Expert Resource client list which includes BASF, Black & Decker, Dow Precision, Hitachi, J.D. Power & Associates, Microsoft Corporation, Northrop Grumman, Quest, and Toshiba, amongst many others. According to Expert Resource, their consultants maintain a 100% success rate of passing the final audit on the first attempt. Solos Endoscopy has posted its updated ISO 13485 CE Mark Schedule on its website, http://www.solosendoscopy.com/investors.html.

About Solos Endoscopy, Inc.:

Solos Endoscopy is celebrating its 25th Year of providing quality innovative healthcare instruments to Hospitals across the Country. For more than 25 Years, from medical schools to hospitals, surgeons have trusted Solos Endoscopy to develop and market breakthrough technology, applications, medical devices, and procedural techniques for the screening, diagnosis, treatment and management of disease and medical conditions.

For more information on TUV SUD America visit www.tuvamerica.com

Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report filing and other filings with the OTC Markets Group (available at www.otcmarkets.com). The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.

Investor Relations
(617) 360-9719


'/>"/>
SOURCE Solos Endoscopy, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Solos Endoscopy Reduces Liabilities by More than $570,000
2. Solos Endoscopys Bariatric Instruments Are Now Available
3. Solos Endoscopy Posts Total Assets of $2,426,883 for Period Ended June 30, 2012
4. Solos Endoscopy Sales Increase by More than 35% for the Month of October
5. Solos Endoscopy Reports Book Value of $2,393,522 for Period Ended September 30, 2012
6. Solos Endoscopy and TUV SUD America Schedule Stage 1 ISO 13485 Audit for February 26, 2013
7. Solos Endoscopy Reports Full Year 2012 Results
8. Middle East and Africa Endoscopy Devices Market Outlook to 2017 - Flexible Endoscopes, Rigid Endoscopes, Endoscopy Visualization Systems, Capsule Endoscope Systems and Others
9. Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ®
10. MarketsandMarkets: Global Endoscopy Market worth $9.7 Billion by 2016
11. Middle East and Africa Endoscopy Devices Market Outlook to 2017 - Flexible Endoscopes, Rigid Endoscopes, Endoscopy Visualization Systems, Capsule Endoscope Systems and Others
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016   Acsis , ... announced that leading IT market research and advisory firm ... in the IDC MarketScape: Worldwide Pharmaceutical Track and Trace ... The report provides an assessment of the capabilities and ... and trace software market. Logo - ...
(Date:4/28/2016)... New market research titled ... report that provides an overview of the Osteoarthritis,s ... identifying new targets and MOAs to produce first-in-class ... in this H1 2016 Osteoarthritis Pipeline report include ... Abiogen Pharma S.p.A., Ablynx NV, Achelios Therapeutics, Inc., ...
(Date:4/27/2016)... , le 27 Avril 2016 ... d,affaires a progressé de +5% sur le trimestre, ... récurrentes de consommables  Croissance de +16% ... Mauna Kea Technologies (Euronext : MKEA, ... d,endomicroscopie confocale laser, annonce aujourd,hui son chiffre d,affaires ...
Breaking Medicine Technology:
(Date:4/29/2016)... Fla. (PRWEB) , ... April 29, 2016 , ... ... Hospital surgeon reveals that infants born with severe congenital diaphragmatic hernia have better ... is born with congenital diaphragmatic hernia (CDH)—a condition where the diaphragm fails to ...
(Date:4/29/2016)... , ... April 29, 2016 , ... Mobility Designed ... put pressure on the armpits, the M+D Crutch evenly distributes body weight from the ... wrists and hands when using the crutches than with other crutches. , Co-founders Max ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Melanoma is the deadliest type of skin ... blame for the majority of skin cancer deaths. More than 10,000 people are expected to ... at diagnosis is 62, it is the one of the most commonly diagnosed cancers in ...
(Date:4/29/2016)... ... 29, 2016 , ... Reltok Nasal Products proudly announces that Boston Medical Products, ... nose and throat specialty, has added the KOTLER NASAL AIRWAY™ to its diverse product ... a newly patented safety device secured by nasal surgeons onto the floor of the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Innovations with Ed ... an upcoming episode, airing third quarter 2016 via Discovery Channel. Dates and show ... Grassland Dairy Products, located in Greenwood, Wisconsin applies product research and development and ...
Breaking Medicine News(10 mins):