CE Marking Consultants for Medical Devices in EU

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) August 17, 2011 -- August 11, 2011; UK: Foraying into the medical industry of any European Union member country requires the CE marking that helps in verification and validation of medical devices, IVDs and active implantable medical devices from domestic as well as international manufacturers and distributors.

Arazy Group is a CE marking consultant and a global medical device consultant that offers medical device registration service and other regulatory services across different global locations. It offers consultancy and expert assistance in achieving CE marking requirements in order to achieve the all-important CE marking certification for launching medical products in the European Union member countries. Hence, whether you are planning to launch your medical product in the UK, Austria, Belgium, Cyprus, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Republic of Ireland, Romania, Slovakia, Slovenia, Spain, Sweden, Netherlands etc, you need the CE markings for your medical devices and IVDs.

The medical devices are subject to Directive 93/42/EEC, the IVD devices are subject to Directive 93/42/EEC and active implantable medical devices are subject to Directive90/385/EEC. The CE markings are mandatory for any medical device manufacturer to enter into any of the countries that are members of the European Union (EU).

Arazy Group offers a wide range of medical device regulatory services to manufacturers and distributors to foray into the respective medical device industries in an EU member country and fulfill the required CE marking norms and specifications. Some of these include:

- Medical Device specific CE Mark regulation strategy reports

- CE Mark Registration of all Medical Devices, IVDs and active implant devices

- Technical File and Design Dossier preparation

- ISO13485 establishment and implementation

- Product validation consultation

- EU Authorized Representative services

- Clinical Research planning and management

- Arazy Group’s unique line of GlobaR - Global Regulatory Hub (Trade Mark) products such as GlobaR Dossier (Trade Mark), GlobaR - One World Process (Trade Mark), GlobaR Submission Center (Trade Mark), and Universal Authorized Representative (Trade Mark).

Arazy Group offers other medical device regulatory services as well including clinical literature review and certification for medical products as per the norms and specifications laid down by the regional regulatory authorities.

Visit Our Website : http://www.arazygroup.com/europe

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