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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.
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

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 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 Registration in Thailand | Medical Device Consultants Thailand - 0 views

arazygroup.com/vice_registration_in_thailand_

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 Thai FDA, Thai Representative and certification holder for Medical Device manufacturers, Thai FDA Technical documents preparation and Arazy Group's.
arazy-group

Medical Devices in Australia | Medical Device Consultants - 0 views

arazygroup.com/ice_registration_in_australia_

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 in Australia, Medical Device Registration with the TGA, Australia Sponsor Representation for Medical Device manufacturers and TGA Technical documents Preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.
arazy-group

Medical Device Registration in South Africa | Medical Device Consultants - 0 views

arazygroup.com/dicalDeviceRegistrationinSouth

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 South African MOH, local Representative and certification holder for Medical Device manufacturers, MCC Technical documents preparation and Arazy Group's unique line of GlobaR - Global Regulatory Hub™ products.
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

Medical Device Registration in Russia | Medical Device Approval Russia - 0 views

arazygroup.com/device_registration_in_russia_

Medical Device Registration Consultants Approval Expert

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Arazygroup.com - Medical Device specific regulation strategy reports, Medical Device Registration with Roszdravnadzor, Technical documents Preparation, obtaining GOST-R quality and safety certification, obtaining sanitary and epidemiological conclusi.
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

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

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

www.arazygroup.com/device_registration_in_russia_

registration in russia Medical Device Safety compliance consultants devices

shared by arazy-group on 18 Jul 11 - No Cached
  • arazy-group on 18 Jul 11
     
    Arazygroup.com - Medical Device specific regulation strategy reports, Medical Device Registration with Roszdravnadzor, Technical documents Preparation, obtaining GOST-R quality and safety certification, obtaining sanitary and epidemiological conclusi.
arazy-group

Medical Device Consultants - 21CFR 820, FDA QSR, cGMP - 0 views

arazygroup.com/FDA-QSR-GMP

Safety compliance device medical consultants devices

shared by arazy-group on 12 Jul 11 - No Cached
  • arazy-group on 12 Jul 11
     
    for any assistance you may need for the preparation or implementation of GMPs. We also provide step by step guidance, external auditing, online consulting and fully outsourced quality assurance maintenance services for your organization.
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