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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

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

Regulatory Authority | Medical Device Services | Universal Authorized Representative Se... - 0 views

www.arazygroup.com/Donotsubmit

regulatory authority medical device services universal authorized representative service AG manufacturer consultant

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

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

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

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 Registration Kuwait | Medical Device Consultants Kuwait - 0 views

arazygroup.com/blog

Medical Device Registration Kuwait Devices Consultants

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Gain medical device compliance and verification from medical device regulatory authorities in Kuwait with expert medical device consultancy services from us. Arazy Group is a global leader in medical device registration and offers a wide range of medical device regulation and clinical clearance services.
  • arazy-group on 26 Jul 11
     
    Gain medical device compliance and verification from medical device regulatory authorities in Kuwait with expert medical device consultancy services from us. Arazy Group is a global leader in medical device registration and offers a wide range of medical device regulation and clinical clearance services.
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

Medical Device Approval | Universal Authorized Representative - 0 views

www.arazygroup.com/SponsorServices

Medical Device Registration Consultants Approval Regulatory

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group Universal Authorized Representative™ service takes away this burden and eliminates the need for multi legal contracts and different foreign currencies.
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

Medical Devices | Material Biocompatibility | ISO 10993 |Medical Device Safety Complian... - 0 views

www.arazygroup.com/Biocompatibility

medical devices material biocompatibility ISO 10993 device safety compliance authorized representative FDA approval process

shared by arazy-group on 07 Jul 11 - No Cached
  • arazy-group on 07 Jul 11
     
    Arazy Group is a major global medical device consultant serving a number of medical developers and manufacturers by providing them with professional and specific knowledge and consulting services in launching their products at a global level.
  • arazy-group on 22 Sep 11
     
    Biocompatibility can be a complex process as many medical devices are made of more than one material. The current leading standard for biological evaluation of medical devices is ISO 10993 at its latest version.
arazy-group

Medical Device Consultants in Malaysia | Medical Device Registration - 0 views

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 22 Jul 11 - No Cached
  • arazy-group on 22 Jul 11
     
    Arazy Group offering a wide range of clinical literature review and regulatory authorities to comply with the important regulatory norms and specifications in the Malaysian medical device industry.
arazy-group

Medical Device Registration in Indonesia | medical device consultants - 0 views

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 22 Jul 11 - No Cached
  • arazy-group on 22 Jul 11
     
    Arazy Group are the leading medical device consultants offering medical device registration in Indonesia and gaining validation and verification for your medical devices and equipment from the important regulatory authorities in the region.
arazy-group

Medical Device Approval Japan | Medical Device Regulatory Vietnam - 0 views

arazygroup.com/_device_registration_in_japan_

device medical devices consultants Safety compliance in Registration Equipment Experts

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Medical Device specific regulation strategy reports, Medical Device Registration with PMDA, Japan Health Technical documents Preparation, Japan Market Authorized Holder and local Representative (MAH), Japan GMP compliance and Arazy Group's unique line of GlobaR - Global Regulatory Hub™ products.
arazy-group

Medical Device Registration in Mexico | Mexico Medical Device Consultants - 0 views

arazygroup.com/device_registration_in_mexico_

device medical devices consultants Safety compliance in Registration Equipment Experts

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Medical Device specific regulation strategy reports, Medical Device Registration with COFEPRIS, COFEPRIS Technical documents Preparation, Mexico license holder and local Authorize Representative and Arazy Group's unique line of GlobaR - Global Regulatory Hub™ products.
arazy-group

Medical Device Registration in India | Medical Device Consultants Southeast India - 0 views

arazygroup.com/_device_registration_in_india_

device medical devices consultants Safety compliance in Registration Equipment Experts

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Medical Device specific regulation strategy reports, Medical Device Registration with India MOH, India MOH Technical documents Preparation, India license holder and local Authorized Representative and Arazy Group's.
arazy-group

Medical Device Consultants Korea | Medical Device Regulatory Korea - 0 views

arazygroup.com/_device_registration_in_korea_

Medical Device Registration Consultants Approval Regulatory

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Medical Device specific regulation strategy reports, Medical Device Registration with KFDA, KFDA Technical documents Preparation, license holder and local Authorize Representative.
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

Sterilization Validation of Medical Devices | Medical Device Safety Compliance | Medica... - 0 views

www.arazygroup.com/Sterilizofedicalevices

sterilization validation of medical devices device safety compliance packaging process IVDD directive sterility assurance level FDA approval effective

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group offer complete third party lab services for medical device packaging and sterilization validation for any device and any risk classification.
  • arazy-group on 22 Sep 11
     
    Medical device manufacturers and distributors in the domestic as well as the international market is welcome to gain market approval and clearance for their medical devices and IVDs through the expert assistance of Arazy Group's incredible team of market experts, medical device industry analyzers, authorized representatives.
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.
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