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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 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

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

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

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

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

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

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

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

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

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

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

Annual Registration Renewal | Product Registration| Professional Consultation | Manufac... - 0 views

www.arazygroup.com/RegistrationRenewal

annual registration renewal product professional consultation manufacture of medical devices special manufacturing process packaging assembling

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group provide online and/or onsite assistance in preparation of any third party audits and our consultant can escort you at the time of the audit.
  • arazy-group on 22 Sep 11
     
    Registration renewal is very important to maintain your product sales clearance and registration for as many years as possible. Renewal of product registration is mandatory in many markets and is subjected to a variety of requirements dictated by local authorities.
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

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

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

SOP | Clean Room procedures | Medical Devices| Manufacture of Medical Devices | Special... - 0 views

www.arazygroup.com/SOP

SOP clean room procedures medical devices manufacture of special manufacturing process packaging assembling quality management system Device

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group Bank of SOPs includes procedures for most of the manufacturing processes practiced in the MedTech industry under various environmental conditions.
arazy-group

21CFR 820 | FDA QSR | cGMP -FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device C... - 0 views

www.arazygroup.com/FDA-QSR-GMP

21CFR 820 FDA QSR cGMP -FDA GMP Audits to 21 CFR Part for Device Companies packaging medical devices assembling

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have enacted that pharmaceutical and medical device companies must follow GMP procedures and have their own criteria that correspond with their legislations.
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).
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