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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 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

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

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

Medical Device Registration in Israel| Medical Device Services | Medical Devices | Medi... - 0 views

www.arazygroup.com/device_registration_in_israel_

medical device registration Israel services devices design FDA regulatory requirements consultant directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in North America. You can introduce your medical device, IVD or medical device equipment into the North America device industry with our expert help and assistance.
arazy-group

Medical Device Registration in Norway| Medical Device Services | Medical Devices | Medi... - 0 views

www.arazygroup.com/device_registration_in_norway_

medical device registration Norway services devices design FDA regulatory requirements consultant directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in Norway. You can introduce your medical device, IVD or medical device equipment into the Norway medical device industry with our expert help and assistance.
arazy-group

Medical Device Design Africa| Medical Device Registration Africa| Medical Device Servic... - 0 views

www.arazygroup.com/africa

medical device design registration Africa services devices FDA regulatory requirements consultant directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
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

Medical Device Registration Australia | Medical Device Services | Medical Devices | Med... - 0 views

www.arazygroup.com/ice_registration_in_australia_

medical device registration Australia services devices design FDA regulatory requirements consultant directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in Australia. You can introduce your medical device, IVD or medical device equipment into the Australian medical device industry with our expert help and assistance.
arazy-group

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

www.arazygroup.com/dicalDeviceRegistrationinSouth

medical device registration South Africa services devices design FDA regulatory requirements consultant directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
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

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

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

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

EU Certificate | EU Certificate of Free Sales| CFS | FDA | EU Health Authority | Medica... - 0 views

www.arazygroup.com/CertFreeSale

EU certificate of free sales CFS FDA health authority device service design consulting Medical registration

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Most foreign health authorities require a manufacturer to present a Certificate of Free Sales (CFS) from the country of origin or the European Union (EU) as part of the requirement for the medical devices import certificate in their territories.
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

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.
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