November 29, 2010, Buenos Aires, AR: Arazy Group has been helping medical device companies in getting CE Mark for the approval of their medical products and equipments in the market. Getting CE MARK symbol is a major requirement these days for international acceptance of medical products.
Marking product with CE symbol means that the particular product or equipment has been evaluated by the regulatory authorities carefully. Moreover, it also means that the product has been found completely safe to use and meet the applicable quality necessities based on the standards approved by the European market (EN, IEC, and ISO).
There are two major categories in which the needs of the CE are divided. These include
Quality system requirements
This is one the major requirements for CE Mark. For the development and manufacturing of the product, it is extremely important for the manufacturer to fulfill quality system requirements.
To meet safety and reliability requirements of the products
This is another important requirement of the product that should be fulfilled. It is important to meet up the safety and reliability requirements of the products. These include items such as electrical safety, electromagnetic compatibility (EMC), biocompatibility, software validation, technical performance evidence, pre-clinical and clinical evidence, performance evidence etc.
Arazy Group has been helping a number of medical device companies in getting CE Mark so that they can introduce their medical products and equipments worldwide.
About Arazy Group:
Arazy Group is a one of the major medical device consultants which have been working in the direction to provide medical developers and manufacturers with international acceptance, right regulatory, marketing approvals such as CMDCAS, SFDA, CE, FDA and KFDA so that they can introduce their products on a global level .
Source(s)
http://www.prlog.org/11108035-ce-mark-for-product-approval-in-bc.html
http://en.wikipedia.org/wiki/Medical_device
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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