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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

Clinical Development Planning | Trial Design Planning | Medical Device Listing | Clinic... - 0 views

www.arazygroup.com/TrialDesignPlanning

clinical development planning trial design medical device listing data project manager regulatory consultant FDA audits

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group team of experienced clinical and regulatory professionals can assist you in developing a comprehensive clinical development strategy for your device at every stage of product development.
  • arazy-group on 22 Sep 11
     
    Arazy Group is a leading global name in medical device consultancy offering a wide range of medical device regulatory services and clinical literature review for medical device manufacturers and distributors in the region.
arazy-group

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

www.arazygroup.com/FDA-PMA

FDA US agents registration regulatory compliance FDA510 device listing FDA-PMA consulting consultin

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

Universal Authorized Representative | FDA Regulatory | Compliance FDA 510 | FDA US Agen... - 0 views

www.arazygroup.com/Univauthorep

universal authorized representative FDA regulatory compliance 510 US agents device listing european medical ISO 13485 design

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    European Union (EU) Authorized Representative, USA Designated agent, China after Sales service, Central & South American registrations holding companies, Japan MAH - Marketing Authorized Holder, Product Sponsor and similar entities are the legal and regulatory bodies a medical device manufacturer needs to source, appoint, contract, pay for and renew annually in order to fully satisfy the product sales clearance requirements.
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

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

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

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

Medical Device Reporting | Devices | Device Vigilance System | FDA Agent | Medical Devi... - 0 views

www.arazygroup.com/VigilanceReport

reporting devices system FDA agent regulatory registration GMP compliance listing Medical Device Vigilance

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    MDR procedure describing a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance System.
  • arazy-group on 22 Sep 11
     
    Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.
arazy-group

EU Health Authority | Medical Device Authority | Medical Device Service |EU Certificate... - 0 views

www.arazygroup.com/ertificateforForeignGovernment

EU health authority medical device service certificate of free sales CFS FDA registration and listing clinical trial management

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    For medical devices cleared for sale with the USA - FDA, a Certificate for Foreign Governments (CFG) can be issued instead of a CFS. Select the "type of service required "available in the attached form for more information of CFG.
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

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

Medical Device Software | Medical Device | FDA | Medical Software Validation | Medical ... - 0 views

www.arazygroup.com/NeedHelpSoftware

medical device software FDA validation design devices regulatory designated agent listing

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group is a leading global name in medical software Validation offering a wide range of medical device regulatory services, medical device software and clinical literature review for medical device manufacturers and distributor around the world.
arazy-group

Exhibitions | Medical Device Reporting | Devices | Device Vigilance System | FDA Agent ... - 0 views

www.arazygroup.com/Exhibitions

exhibitions reporting devices system FDA agent regulatory registration GMP compliance listing Medical Device Vigilance

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.
arazy-group

Choosing a reliable Medical Device Expert - 0 views

arazygroup.blogspot.com/...ble-medical-device-expert.html

Medical Device Expert consultor Advisor

shared by arazy-group on 08 Sep 11 - No Cached
  • arazy-group on 08 Sep 11
     
    Medical device experts play a significant role in the successful launch of a medical device or equipment on a global level. It is extremely important to choose an expert carefully. Some of the major points that need to be kept in mind have been listed below.
arazy-group

Medical Software Validation | Medical Device Software Validation | Medical Device Desig... - 0 views

www.arazygroup.com/SoftwareValidation

medical software validation device design devices regulatory designated agent listing FDA

shared by arazy-group on 07 Jul 11 - No Cached
  • arazy-group on 07 Jul 11
     
    Arazy Group has been assisting medical device companies to a large extent in the launch of their products and equipment at a global level.
  • arazy-group on 22 Sep 11
     
    Arazy Group is one of the leading global names in medical software Validation offering a wide range of medical device regulatory services, medical device software and clinical literature review for medical device manufacturers and distributor around the world.
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