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FDA US Agents | FDA Registration US | FDA Regulatory | Compliance FDA 510 | FDA US Agen... - 0 views

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    Arazy Group offers 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

Europe Union | Medical Devices |IVD Devices | IVD| CE Mark Registration | Active Implan... - 0 views

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    Medical devices are divided into class I, IIa, IIb and III. IVDs are divided into four categories: General IVDs, self-diagnostics, list A and list B. All medical devices exempt class I and General IVDs require the involvement of a Notified Body and the implementation of a quality management system, usually in line with ISO 13485.
arazy-group

Usability Studies | FDA | Medical Device Design | FDA Medical Device | Medical Device R... - 0 views

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    Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.
arazy-group

Clinical Evaluation through Literature Review | Clinical Literature Review |Medical Dev... - 0 views

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    Gain CE Mark approval and fulfill the CE mark requirements with the help of our global experts and team of qualified marketing professionals, regulatory specialists, scientists and the best brains behind achieving product validation for medical device manufacturers and distributors around the world.
arazy-group

Clinical Research Administration, High Quality Clinical Research | ISO 1348 | 510K Appr... - 0 views

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    The Clinical Research Administrator facilitates the timely execution and completion of high-quality clinical research by assisting investigators and industry sponsors with all aspects of the clinical research.
arazy-group

Technical File Preparation | CE Mark Certification | Medical Device Regulation | CE Mar... - 0 views

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    Arazy Group is a leading medical device consultant that provides medical device manufacturers with international acceptance, right product validation, medical device registration, product regulatory and marketing approvals to help them gain market approval for their medical devices and equipment.
arazy-group

Arazy Group | Medical Device Consultants | CE Mark consultants - 0 views

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    http://www.arazygroup.com/europe - CE Mark consultants for medical device validation, clearance and certification throughout the European Union.
arazy-group

European Authorized Representative | Medical Devices | CE Mark Consultancy | Medical De... - 0 views

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    Arazy Group European Authorized Representative is Medes Limited UK. Located in Radlett, Hertfordshire, Medes is a qualified and recognized Authorized Representative.
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    Arazy Group European Authorized Representative is Medes Limited UK. Located in Radlett, Hertfordshire, Medes is a qualified and recognized Authorized Representative. We have been serving hundreds of companies worldwide since 1996.
arazy-group

Global Medical Device Service | GMDN | European Authorized Representative | Medical Dev... - 0 views

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    Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
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    GMDN or Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
arazy-group

Italian NSIS Repertorio Registration | Medical Devices | CE Marked | National Regulatio... - 0 views

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    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
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    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
arazy-group

US FDA Agent | Medical Device Registration | Medical Devices | CE Marked | National Reg... - 0 views

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    Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent.
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    Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent. We have been serving hundreds of companies worldwide since the new FDA regulation came into force on April 2002.
arazy-group

Product Registration Spanish Database | Medical Device Registration | Clinical Trial Mo... - 0 views

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    Gain CE Mark approval and fulfill the CE mark requirements with the help of our global experts and team of qualified marketing professionals, regulatory specialists, scientists and the best brains behind achieving product validation for medical device manufacturers and distributors in Europe.
arazy-group

FDA Consulting | FDA Consulting Privacy Policy | Medical Device Consultant| EMC Certifi... - 0 views

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    Medical device companies have faced regulatory, technological, reimbursement and market risks always. It can be said that these risks are not new, a new risk is added to the present set of challenges and that risk is called as financing risk.
arazy-group

Quality System Audits | Medical Device | IVD Equipment | CE Mark | QMS Activities | FDA... - 0 views

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    Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.
arazy-group

FDA 510 | FDA US Agents | FDA Device Listing | FDA US Agents | FDA Registration US | FD... - 0 views

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    Arazy Group help you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you. You can gain from our numerous medical device regulatory and CE marking consulting services.
arazy-group

Medical Device Registration | Global Medical Device Registration | Medical Devices Stan... - 0 views

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    As an international company, we make sure we are available to our clients around the clock through various channels of communication in multiple languages.
arazy-group

Clinical Study Management, Clinical Development Planning |Medical Device Regulatory| Me... - 0 views

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    Clinical trials planning and design are based on the therapeutic principles, regulatory standards and guidance documents, background literature and labeling of equivalent products.
arazy-group

Essential Requirements | Medical Device | FDA |Regulatory Designated Agent | FDA Device... - 0 views

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    Arazy Group - Preparation of a regulatory dossier for the authorities can be cumbersome as It may contain tens of different documents, templates, reports, charts and graphics.
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    Arazy Group helps you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you.
arazy-group

Medical Device Services South Africa| Medical Devices |Medical Device Registration Sout... - 0 views

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    Arazy Group, a Universal medical device consultant, offers medical device verification, validation as well as certification services in South Africa.
arazy-group

Arazy Group | Medes | MDC | FDA certification - 0 views

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    http://www.www.arazygroup.com/US-FDA-Agent - Medical device validation, FDA certification, CE Mark clearance, and regional medical device registration and global authorized representatives.
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