December 4, 2010, Buenos Aires, AR: Arazy Group has been supporting a number of medical developers and manufacturers by conducting various software validation tests of their products and equipments, which is one of the major requirements for global launch of products.
Every medical equipment or device which includes software is required to pass through different levels of software validation tests to avoid any kind of risks. This is an important consideration for getting international acceptance. The software validation testing procedure involves a number of important steps. The medical device manufacturers are required to present documentation of six steps which includes:
• Risk evaluation document.
• Software Requirements Specifications (SRS) document.
• Software Test Procedure and Software Test Plan Specification document.
• Software Test Reporting form.
• Synopsis of test results.
• Configuration management plan and software quality assurance plan.
A large number of medical device manufacturers have been deriving support from Arazy Group in passing through the software validation tests thus introducing their products on an international level.
In addition to software validation tests, Arazy Group has also been helping medical companies in getting evaluation from proper public health authorities, regulatory sales clearances and marketing approvals such as CMDCAS, SFDA, CE, FDA and KFDA.
About Arazy Group:
Arazy Group is a medical device consultant which has been working in the direction to provide medical developers and manufacturers with evaluation from proper public health authorities, regulatory sales clearances and marketing approvals such as CMDCAS, SFDA, CE, FDA and KFDA with an aim to help them launch their products internationally.
Source(s)
http://www.prlog.org/11124511-software-validation-tests-for-global-launch-of-products.html
http://www.free-press-release.com/news-software-validation-tests-for-global-launch-of-products-1291447100.html
Medical Device Consultants | Medical Devices Experts | Medical Lab Equipment
Arazy Group - Medical Device Consultants | Medical Device Registration
Arazy Group expertise is regulatory affairs and quality assurance for the medical device industry. We specialize in marketing safe and effective Medical Technology to international markets. Our experienced consultants are responsible for the successful registration of thousands of medical devices globally. Our customized solutions accommodate all stages of medical device's life cycle and our adaptable services fit any application and any size organization.
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