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

www.arazygroup.com/ClnLiterRev

clinical evaluation through literature review medical device regulatory CE marking consultants approval

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

www.arazygroup.com/TechnicalFilePreparation

technical file preparation CE mark certification medical device regulation consultants FDA approval process directive submission regulatory registration 93_42 EEC ISO 1448

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

www.arazygroup.com/UserabilityStudies

usability studies FDA medical device design regulations CE marking Consultants approval process mark EMC certification

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.
arazy-group

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

www.arazygroup.com/StudyManagement

clinical study management development planning medical device regulatory CE marking consultants approval

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

www.arazygroup.com/ResearchAdministration

clinical research administration high quality ISO 1348 510 approval MDD 93 42 CE markings marking certification FDA medical device regulation

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

youtu.be/ikU-QTSGZ_g

CE Mark consultants medical device validation

shared by arazy-group on 07 Sep 11 - No Cached
  • arazy-group on 07 Sep 11
     
    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

www.arazygroup.com/EuropeanAuthRep

European authorized representative medical devices CE mark consultancy device services EU market regulatory affairs consultants designated agent

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group European Authorized Representative is Medes Limited UK. Located in Radlett, Hertfordshire, Medes is a qualified and recognized Authorized Representative.
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/GMDNCoding

global medical device service GMDN European authorized representative devices CE mark consultancy services EU market regulatory affairs consultants designated agent

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    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 on 22 Sep 11
     
    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

www.arazygroup.com/NSISRepertorio

Italian NSIS repertorio registration medical devices CE marked national regulation device FDA consulting listing and diagnostic industry clinical trial data management

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    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 on 22 Sep 11
     
    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

www.arazygroup.com/US-FDA-Agent

US FDA agent medical device Registration devices CE marked national regulation consulting listing and diagnostic industry clinical trial data management

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent.
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/tRegistrationinSpanishDatabase

product registration Spanish database medical device clinical trial monitoring GMP european regulatory FDA listing vigilance

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/PrivacyPolicy

FDA consulting privacy policy medical device consultant EMC certification CE marking regulatory approval directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/QualitySystemAudits

quality system audits medical device IVD equipments CE mark QMS activities FDA Taiwan regulation health Canada CMDCAS service professional ISO1348

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/FDA510KFilePreparation

FDA 510 US agents device listing registration regulatory compliance ISO 13485 and requirements

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/registrationinmorethan53countr

medical device registration global devices standards regulatory consulting CE marking FDA agent ISO 13485 consultant clinical project manager

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

www.arazygroup.com/europeanunion

Europe union medical devices IVD mark registration active implant design dossier preparation ISO 13485 eu authorized representative service ce marking markings FDA 510k

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    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

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

www.arazygroup.com/esRegulatoryDossierPreparation

essential requirements medical device FDA regulatory designated agent listing USA agents registration US compliance ISO 13485 and

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    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.
  • arazy-group on 22 Sep 11
     
    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

www.arazygroup.com/southfrica

medical device services South Africa devices registration FDA regulatory requirements listing diagnostic industry CE mark consultancy

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group, a Universal medical device consultant, offers medical device verification, validation as well as certification services in South Africa.
arazy-group

Regulatory Dossier Preparation | Medical Device Safety Compliance | Medical Device Regu... - 0 views

www.arazygroup.com/EssentialRequirements

regulatory dossier preparation medical device safety compliance clinical trial data FDA US agents reporting registration and listing

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    A team of professional medical device regulatory and quality experts are here to assist you with writing, reviewing or editing of an "Essential Requirements" table, a complete CE technical file, a traditional 510k or a complicated PMA file.
arazy-group

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

youtu.be/j-7S55pFkF4

device validation FDA certification medical registration

shared by arazy-group on 07 Sep 11 - No Cached
  • arazy-group on 07 Sep 11
     
    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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