November 30, 2010: Arazy Group is a medical device consultant which performs several tasks for clients like bringing market approvals from essential public health authorities, brings clinical evaluation, CMDCAS approval and much more.
Medical devices are needed to go through different section to prove their capability, quality and affectivity as well. And quality assurance of medical equipments is important to make them suitable for international market.
As far as quality assurance of medical devices of Arazy Group is considered. Products which are three years old are needed to get high quality standard assurance. Device manufacturing companies are needed to come with the standards accepted by the target market authorities like:
• The quality standards of European authorities including the ISO 13485:2003 and the ISO 9001:2000. Such standards are active in different European Community countries and are applicable with the 93/42 EEC Medical Device Directives.
• QSR which stands for Quality System Regulation is published by FDA which is an American regulatory agency.
• Medical Device Regulations document is published by Canadian ministry of health which refers the ISO 13485:2003.
Other countries come with different medical device standards which can be easily implemented as per the request of medical device producing companies in UK, EU member states, North and South America, Far East and Middle East.
About Arazy Group:
Arazy Group brings market approvals to medical devices through its branches in Middle East, EU member states, Far East, South America and many others. Its special feature includes bringing FDA Clearance, clinical evaluation, CMDCAS approval and much more to medical devices before presenting them in international market.
Source(s)
http://www.prlog.org/11111421-quality-assurance-of-medical-devices.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.
Tuesday, November 30, 2010
Monday, November 29, 2010
CE Mark for Product Approval in BC
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
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
Wednesday, November 24, 2010
Demonstration of Medical Product Compliance
November 25, 2010: Arazy Group brings regulatory sales clearances to medical devices in London, UK. It has its branches in different parts of the world. It has been assisting its clients by offering demonstration of medical product compliance.
Medical devices are needed to come with safe to use features. And numerous public health authorities are there whose approval is required before availing them in the market.
As far as medical product compliance of Arazy Group is concerned, it has been divided into six services like:
• Electrical safety is checked to verify the affectivity and safety of battery.
• Electromagnetic compatibility tests are also performed to find out the electromagnetic effectiveness of products.
• Implementation of labeling process is another way to check out the safety requirements of medical devices.
• Software validation tests based on standards of FDA and IEEE are there to prove medical products as safe and effective for potential customers.
• To check devices are free of microbes and virus, sterilization test are there to analyze the products.
• Biocompatibility tests are required to verify products are non-toxic and don’t cause any allergic reaction.
For any of these services, medical device producing companies can contact to Arazy Group and can grab more information regarding medical product compliance.
About Arazy Group:
Arazy Group is a medical product consultant which works to demonstrate the effectiveness and safety features of products. Its different kind of services includes labeling, electrical safety, software validation, biocompatibility tests and several other services in London, UK.
Source(s)
http://www.prlog.org/11096530-demonstration-of-medical-product-compliance.html
Medical devices are needed to come with safe to use features. And numerous public health authorities are there whose approval is required before availing them in the market.
As far as medical product compliance of Arazy Group is concerned, it has been divided into six services like:
• Electrical safety is checked to verify the affectivity and safety of battery.
• Electromagnetic compatibility tests are also performed to find out the electromagnetic effectiveness of products.
• Implementation of labeling process is another way to check out the safety requirements of medical devices.
• Software validation tests based on standards of FDA and IEEE are there to prove medical products as safe and effective for potential customers.
• To check devices are free of microbes and virus, sterilization test are there to analyze the products.
• Biocompatibility tests are required to verify products are non-toxic and don’t cause any allergic reaction.
For any of these services, medical device producing companies can contact to Arazy Group and can grab more information regarding medical product compliance.
About Arazy Group:
Arazy Group is a medical product consultant which works to demonstrate the effectiveness and safety features of products. Its different kind of services includes labeling, electrical safety, software validation, biocompatibility tests and several other services in London, UK.
Source(s)
http://www.prlog.org/11096530-demonstration-of-medical-product-compliance.html
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