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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 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

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.
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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.
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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

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

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.
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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.
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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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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.
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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

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 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

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.
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