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Congratulations to Argo Medical: received FDA approval in the REWALK using QPack system to produce documents submission

June 28th, 2014 Posted by ALM 2.0, Company, Company News, Customers, FDA, IEC 62304, ISO 13485 0 thoughts on “Congratulations to Argo Medical: received FDA approval in the REWALK using QPack system to produce documents submission”

system allows paralyzed to stand and walk independently; Approval is expected to help the company realize its plans to go public or be sold at a high price

Argo Medical Corporation announced today (Friday) on receiving FDA approval for company’s REWALK system which allows paralyzed to go with it. Certification will be conducted with the help paralyzed in their homes, which until now have only been able rehabilitation centers. According to estimates, is expected to help the company realize certificate programs to its issuance, or alternatively to be sold at a high price. The submission process led the Israeli team in collaboration with the American team using Orcanos QPack medical manages the production of all documents, including changes in content in software validation documents along with Traceability tables automatically generated with non-contact person.

עמית גופר

Amit Goffer

Last March revealed “Kalkalist” Argo Medical intention to go public on NASDAQ at a value of $ 250 million – the value may even be higher if the company will issue shortly.

QPack Medical System is a system for managing development processes and quality for companies and manufacturers of Medical Equipment, containing the largest number of processes in one system integratively. Recently Orcanos released the seventh generation of the system and added two primary processes in Medical device product quality system. One document management system that includes electronic signatures subject to the conditions of 21 CFR Part 11 and the other, customer complaints management system in accordance with ISO 13485 section 4.2. These additions allows Orcanos SMB market also to handle the development of small firms in relation to changes in the process of quality. Also Orcanos added a new key component that enables us to work with external subcontractors and document changes QPack Web which saves time synchronization.

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company, located in Yokneam, founded by Dr. Amit Goffer, four limbs paralyzed himself . The company, established in 2001, currently employs 50 employees in Israel and around the world. The system developed has received numerous awards and was shown at various events over the years, including President Barack Obama during his visit to the country.

Japanese Yaskawa Corporation (YASKAWA Electric) is considered a leading candidate to buy the company. Last year Argo Medical signed the strategic cooperation agreement with the corporation, which invested $ 10 million in the company, and signed her exclusive distribution agreement in Japan and China and the creation of customer service in Singapore, Thailand, Btayewan and South Korea. With investors include Life Sciences Fund also VitaLife Foundation, nitroprusside and Pontifax Fund.

According to reports, Argo has about 30 centers in the world who offer the system, and 200 who were trained to be assisted paralyzed her.

ReWalk is an exoskeleton suit that enables people with disabilities and lower limbs paralyzed stand and walk independently without assistance. Exoskeleton suit battery operated daily prolonged use, allowing the user convenience without having to recharge. ReWalk system is controlled by a computer and motion sensors, and controls movement through subtle changes in center of gravity, mimics natural gait and walking speed provides functional.

Core Study Cast Medical Technologies located in the USA selected Orcanos QPack Medical ALM solution

April 23rd, 2013 Posted by Customers, Events 0 thoughts on “Core Study Cast Medical Technologies located in the USA selected Orcanos QPack Medical ALM solution”

Orcanos Welcome Core Study Cast,

 Studycast®is a web-based medical imaging software that has been clinically proven to deliver the results that physicians, technicians, and administrators require. Studycast’s cloud PACS can fit into any facility infrastructure.

Studycast Cloud PACS Allows You To:

  • Transmit diagnostic data and ultrasound images securely
  • View those studies virtually anywhere with internet access
  • Interpret data and create reports quickly
  • Store & Share studies and images securely in the cloud. Studycast is HIPPA/HITECH compliant!
  • Integrate your final reports to your EMR seamlessly
  • Manage workflow and monthly reports.  For more information visit http://www.corestudycast.com

 

Core Study Cast has selected Orcanos solution QPack Medical™ to lead their upcoming new software development lifecycle SDLC which is stands for regulation and standard that needs to meet market goal that are extremely aggressive which involves 510K and other requirements. QPack system will support Core Study Cast full lifecycle change management process and software validation as well and will be producing all relevant document for Invasix customers/partners. The project also includes integrative work with existing legacy system at Invasix. At the same time Invasix latest approval by the FDA expose Orcanos solution to top industry suppliers now to examine QPack Medical™ support the validation procedure required by IEC 62304, IEC 62366, ISO 14971 and 60601 3rd edition for Computerized System, Information Technology and others. Having Invasix under Orcanos list of customers serves Orcanos agenda in the past 5 year to be a leader solution provider for the Medical Device and aligned industries such as Pharmaceutical and Bio-Tech. We have been continuously working on QPack Medical™ to meet every change by the authorization body requirements and standards. We are now moving forward with the Mobile Health changes and completing our product to allow small application vendors to be able to reduce the cost of compliancy by streamlining all the data under single repository – QPack Medical™

 

 

ATI – Advanced Medical Technologies selected Orcanos QPack Medical ALM solution

July 23rd, 2012 Posted by Customers, Events 0 thoughts on “ATI – Advanced Medical Technologies selected Orcanos QPack Medical ALM solution”

Orcanos Welcome ATI,

ATI Advanced Medical Technologies is a developer of non-invasive diagnostic devices for the ophthalmology market. The Company has two products in its portfolio, a non-invasive pupil dilation device, called the FIM and a non-invasive tonometer to measure intraocular pressure, called the NIT. 

ATI has selected Orcanos solution to support their product development lifecycle SDLC which is stands for regulation and standard that needs to meet with 510K and other requirements. QPack system will support ATI change management process and software validation as well and will be producing all relevant document for ATI customers. At the same time ATI exposure to top industry suppliers now to examine QPack support the validation procedure required by IEC 62304, IEC 62366, ISO 14971 and 61601 3rd edition for Computerized System, Information Technology and others. Having ATI under Orcanos list of customers serves Orcanos agenda in the past 5 year to be a leader solution provider for the Medical Device and aligned industries. We have been continuously working on QPack Medical™ to meet every change in authorization body requirements and standards. We are now moving forward with the Mobile Health changes and completing our product to allow small application vendors to be able to reduce the cost of compliancy by streamlining all the data under single repository – QPack Medical™.

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