Professional Medical Device Consultants in BC

December 17, 2010, Buenos Aires, AR: Arazy Group is a medical device consultant which has been helping a number of medical device companies for getting marketing approvals so that they can launch their products worldwide. 

It is very important for medical device companies to receive marketing approvals in order to launch their products globally. Arazy Group has been helping them in this regard by providing all necessary marketing approvals like CE, FDA, CMDCAS, SFDA, KFDA etc.

In addition to marketing approvals, the medical device consultant also provides the medical device companies with regulatory sales clearance to provide recognition for their products in the international market. 

Clinical evaluation is also an important consideration for international acceptance of medical products and devices. Not all but some of the products need clinical trials approval. Arazy Group has been helping companies in this regard by providing them with clinical evaluation.

Approval from health authorities is also very important to get international acceptance. The medical device consultant is also assisting companies in this regard.

Thus, it can be said that Arazy Group has been serving up medical companies to a large extent by providing them with marketing approvals so help them introduce their products on a global level. 

About Arazy Group:

Arazy Group is one of the major medical device consultants which have been serving various medical developers and manufacturers in getting international acceptance, right regulatory and a number of other important marketing approvals.  This way, the company is helping them a lot for getting international acceptance for their products.

Source(s)
http://www.prlog.org/11154804-professional-medical-device-consultants-in-bc.html
http://www.free-press-release.com/news-professional-medical-device-consultants-in-bc-1292481516.html

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FDA Clearance for Global Launch of Products

December 15, 2010, Buenos Aires, AR: A large number of medical developers and manufacturers are there who are seeking help from Arazy Group in getting FDA Clearance for international acceptance of their products. 

It is extremely important for any medical device developer or manufacturer to receive FDA Clearance in order to get a worldwide recognition for their products. Only after getting FDA evaluation, they can launch their products and equipments on a global level. Otherwise, no matter how good the products are, without FDA approval, international market will not accept them.  

Arazy Group fulfills certain important requirements of the company for getting FDA Clearance. These include:

•    The company helps in the organization of medical quality management system which is regarded as one of the primary concerns for receiving FDA Clearance.  Arazy Group has been helping companies establish as well as maintain a Medical Quality Management System capable of fulfilling the GMP/QSR requirements.

•    Company Registration with FDA is another important consideration which needs to be fulfilled by medical developers. They need to register their company with FDA in order to get clearance.

•    Moreover, the medical device consultant has also been helping the medical developers in the building and compliance of product clearance application file.

Thus, it can be said that the medical device consultant is playing an increasingly important role by helping medical developers and manufacturers in getting FDA Clearance for international acceptance of their products.

About Arazy Group:

Arazy Group is a primary medical device specialist which has been working in the direction to provide medical developers and manufacturers with right regulatory, international acceptance and other marketing approvals to assist them launch their products internationally.

Source(s)  
http://www.prlog.org/11151996-fda-clearance-for-global-launch-of-products.html
http://www.ideamarketers.com/?articleid=1721967&CFID=49763256&CFTOKEN=57631165

Arazy Group Demonstrating the Effectiveness of Products

December 14, 2010, Buenos Aires, AR:  A large number of medical device companies take help from Arazy Group to make their product  appeal to potential markets. To make any product appeal to potential market, it is very important to check its safety and effectiveness. Arazy Group is one of the chief medical device consultants which have been helping innumerable medical device companies in this regard.

The products need to undergo a number of clinical trials and other types of testing in order to ensure and demonstrate their effectiveness. To assure safety, the product has to go through a battery of specific tests performed by certified laboratories to demonstrate that the device is secure both for the user as well as the patient. Arazy Group helps companies achieve this goal.

The medical device consultant finds out the battery of tests appropriate for the product as per its nature. Apart from this, the company also implements an appropriate labeling process to guarantee the safety of products. Arazy Group provides companies with an evaluation of the labeling carried out by its professionals.

This way, Arazy Group has been assisting medical developers and manufacturers all over the world in fulfilling all chief requirements for their products thus helping them to introduce their medical devices or medical lab equipments worldwide.

About Arazy Group:

Arazy Group is one of the primary medical device consultants which have been furnishing a majority of medical developers and manufacturers with right regulatory, FDA Clearance, evaluation by health authorities and various other marketing approvals to help them launch their products internationally.

Source(s)
http://www.prlog.org/11145597-arazy-group-demonstrating-the-effectiveness-of-products.html

Medical Products Introduction at Global Level

For introduction of medical devices and medical lab equipments at a global level, it is extremely important to receive a number of approvals from divergent authorities.

If any company is planning to manufacture any medical device or medical lab equipment, the most important point that should be kept in mind is the introduction of that particular product at global level.  Even if the products manufactured are of high quality, they require approvals from various authorities. These approvals are very important for continuation of business and helps in the introduction of medical devices or lab equipments in international market.

The article explains some of the important approvals a company requires for introducing its products at a global level. These are:

Marketing approvals

If a medical device company wants to bring its product in the international market then that product needs to get market approvals such as CE, FDA, CMDCAS, SFDA, KFDA etc' first. Once it has been approved by CE, FDA, CMDCAS, SFDA, KFDA, it easily gets global acceptance.

Evaluation from public health authorities

In order to introduce any product at an international level, medical device importers, producers or inventors require evaluation from public health authorities. The international market will accept these products only after getting evaluation from public health authorities.

Regulatory sales clearances

Receiving proper regulatory sales clearances is also important for global introduction of medical products and equipments.

Clinical assessment

Most of the products require clinical trials approval also. Only after getting such approvals, these products can get international acceptance.

In order to get all these approvals, businesses can take help from medical device consultant firms. Many medical device consultant firms have been emerged which are playing an important role of introducing various products at a worldwide level.

Source(s)
http://ezinearticles.com/?Medical-Products---Introduction-at-Global-Level&id=5374927 

Evaluation from Public Health Authorities

December 7, 2010, Buenos Aires, AR: Arazy Group is a medical device consultant which has been helping a number of medical device manufacturers in launching their products at a global level by providing the products with proper evaluation from the public health authorities.

If the products have not been evaluated by proper public health authorities, international market would not accept them, no matter how excellent these are. For this purpose, all medical device manufacturers are dependent on medical device consultants like Arazy Group who have been helping these companies by providing their medical devices or medical lab equipments with assessment from public health authorities.  

Some of the important features associated with Arazy Group include:

Specific knowledge and consulting services

Arazy Group has been providing thousands of international medical and Lab equipment companies with the specialized and precise information and consulting services to help them introduce their products and equipments internationally with lot of ease.

Available in different areas

Arazy Group is an international company with branches available in the UK as well as other EU member states, Middle East, Far East, North and South America, liaison co-operations in Turkey, India and Japan.

Other services

In addition to evaluation from public health authorities, Arazy Group also provides various medical device companies with other marketing approvals like CE, FDA, CMDCAS, SFDA, KFDA and clinical evaluation, FDA Clearance also.

About Arazy Group:

Arazy Group is a leading medical device consultant which has been providing a number of medical device manufacturers with market approvals like CE, FDA, CMDCAS, SFDA and KFDA. Moreover, it also provides them with clinical evaluation, FDA Clearance as well as evaluation from public health authorities for the international acceptance of their products.

source(s)
http://www.prlog.org/11127270-evaluation-from-public-health-authorities.html

Software Validation Tests For Global Launch of Products

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

Quality Assurance of Medical Devices

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

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

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