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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

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

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

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

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

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

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

Universal Authorized Representative | USA Designated Agent | Global Regulatory Represen... - 0 views

www.arazygroup.com/inquiry_form.php

universal authorized representative USA designated agent global regulatory representation service consultant Medical Device FDA registration consulting

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group Universal Authorized Representative™ service takes away this burden and eliminates the need for multi legal contracts and different foreign currencies.
  • ...2 more comments...
  • arazy-group on 22 Sep 11
     
    Arazy Group Medical Devices Consultant is a reputed medical device consultant for medical device registration in Japan and deals with quality medical devices. In fact it is a global medical device consultant offering registration of medical device services in more than 53 countries.
  • arazy-group on 22 Sep 11
     
    Arazy Group is a leader in medical device consultancy and medical device registration services throughout the world. Professional medical device consultants are available to help the companies to avoid problems or risks related to regulation.
  • arazy-group on 22 Sep 11
     
    Medical device industry is counted among industries that play effective role in the society. They come up with quality medical devices which are quality tested and authorized by medical researchers and regulatory specialists to ensure the safety and effectiveness of devices.
  • arazy-group on 22 Sep 11
     
    Arazy Group Universal Authorized Representative™ service takes away this burden and eliminates the need for multi legal contracts and different foreign currencies. AG Universal Authorized representative™ services is your single source for a global regulatory representation.
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

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.
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

IVD | GMP Certificates| Medical Device Manufactures | Vitro Diagnostics Products | Audi... - 0 views

www.arazygroup.com/Brazil-GMP

IVD GMP certificates medical device manufactures vitro diagnostics products audit manufacturers Brazil modification regulatory designated agent affairs consultants vigilance

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Foreign and local medical device manufacturers are now required to be inspected and be in compliance with the Brazilian Good Manufacturing Practices requirements prior to the submission of their devices for registration with ANVISA, the Brazilian authority in charge of the medical devices and IVDs clearance.
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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