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Medical Device Consultants | Risk Management Report - 0 views

www.arazygroup.com/RiskAnalysis

Risk Analysis Management Report Medical Device Registration Consultants Approval Regulatory

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Medical Device Risk Management and Risk Analysis, Medical Device Risk Analysis, Risk Management for Medical Devices, For more information, please submit your inquiry or choose to consult our online experts right now.
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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.
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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.
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Canadian Medical Devices Conformity | CMDCAS Canadian Medical Device Conformity - 0 views

arazygroup.com/CanadaCMDCAScompliance

device medical devices consultants Safety compliance in Registration Experts

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    To register of a medical device in the Canadian market a quality management systems must be applied for all medical devices manufacturer except class for I devices. Canadian Medical Devices Conformity, CMDCAS Canadian Medical Device Conformity, Canada.
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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

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.
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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

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

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.
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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.
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.
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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.
arazy-group

Medical Device , ANMAT GMP QMS System Implementation - 0 views

www.arazygroup.com/AnmatGMPQMS

Safety compliance device medical consultants devices

shared by arazy-group on 15 Jul 11 - No Cached
  • arazy-group on 15 Jul 11
     
    Any company that wants to manufacture or import medical devices in Argentina must have a Quality Management System in compliance with ANMAT's GMP. ANMAT GMP QMS System Implementation, Anmat GMP QMS System Implementation.
arazy-group

Canadian Medical Devices Conformity Assessment - 0 views

www.arazygroup.com/CMDCAS

Canadian Medical Devices Conformity CMDCAS Device Assessment

shared by arazy-group on 15 Jul 11 - No Cached
  • arazy-group on 15 Jul 11
     
    To register of a medical device in the Canadian market a quality management systems must be applied for all medical devices manufacturer except class for I devices. Canadian Medical Devices Conformity, CMDCAS Canadian Medical Device Conformity, Canada.
arazy-group

medical device consultants , ISO13485 Quality Management System - 0 views

arazygroup.com/QualityManagementSystem

Medical Device Safety compliance consultants devices

shared by arazy-group on 12 Jul 11 - No Cached
  • arazy-group on 12 Jul 11
     
    Arazy Group provide training, step by step guidance, external auditing and online consulting. Also, we fully outsource quality assurance maintenance services for your organization.
arazy-group

Electromagnetic Compatibility (EMC), Medical device - 0 views

www.arazygroup.com/ElectromagneticCompatibility

Safety compliance device medical consultants devices

shared by arazy-group on 07 Jul 11 - No Cached
  • arazy-group on 07 Jul 11
     
    As far as the team of Arazy Group is concerned, it comprises of regulatory specialists, clinical researchers, scientists, medical experts and quality assurance managers with deep knowledge and understanding of the Medical Device and the IVD industries.
arazy-group

Specializes in Medical Devices, Medical Device Consulting Firms - 0 views

arazygroup.com/ContactUs

Medical Device Regulatory Consulting Specializes in Devices Firms Manufacturers

shared by arazy-group on 06 Jul 11 - No Cached
  • arazy-group on 06 Jul 11
     
    Arazy Group comprises of a team of clinical researchers, quality assurance managers, medical experts and regulatory specialists who have in-depth experience in the medical device and the IVD industries.
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