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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

Medical Device Consultants in Brazil - 0 views

arazygroup.com/blog

Device Safety compliance medical consultants devices

shared by arazy-group on 22 Jul 11 - No Cached
  • arazy-group on 22 Jul 11
     
    Arazy Group is one of the leading medical device consultants in Brazil that offers expert regulatory services and medical device registration in Brazil for a wide variety of medical products, equipment, etc. Professional consultants of the company have more than 15 years of experience in this domain and have successfully registered thousands of medical devices in Brazil.
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

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

Medical device registration Oman | Medical Device Consultants Oman - 0 views

arazygroup.com/blog

Medical registration Oman Devices Device Consultants

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Depend on the international standard medical device consulting services of Arazy Group, global leaders in medical device registration and clinical clearance. We offer quality and proven medical device registration in Oman to medical device manufacturers and marketers eyeing the region to introduce their new set of medical products.
  • arazy-group on 26 Jul 11
     
    Depend on the international standard medical device consulting services of Arazy Group, global leaders in medical device registration and clinical clearance. We offer quality and proven medical device registration in Oman to medical device manufacturers and marketers eyeing the region to introduce their new set of medical products.
arazy-group

Medical device registration Jordan | Medical Device Consultants Jordan - 0 views

arazygroup.com/blog

Medical registration Jordan Devices Device Consultants

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    Gain compliance with the Ministry of Health (MOH) in Jordan for your medical products with the aid of world leading medical device consultants. Arazy Group helps you introduce and foray into the Jordanian market with your medical devices and equipment like no other medical device consultant.
  • arazy-group on 26 Jul 11
     
    Gain compliance with the Ministry of Health (MOH) in Jordan for your medical products with the aid of world leading medical device consultants. Arazy Group helps you introduce and foray into the Jordanian market with your medical devices and equipment like no other medical device consultant.
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

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

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

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

FDA Clearance for Global Launch of Products - 0 views

arazygroup.blogspot.com/...ance-for-global-launch-of.html

FDA Clearance Medical Device approval

shared by arazy-group on 08 Sep 11 - No Cached
  • arazy-group on 08 Sep 11
     
    A large number of medical developers and manufacturers are there who are seeking help from Arazy Group in getting FDA Clearance for international acceptance of their products. 
arazy-group

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.
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

Major Challenges of Medical Device Industry - 0 views

arazygroup.blogspot.com/...llenges-of-medical-device.html

Medical Device Industry industries technology

shared by arazy-group on 08 Sep 11 - No Cached
  • arazy-group on 08 Sep 11
     
    Every industry has been facing several challenges to deliver best of products and services. Medical device industries have always faced challenges related to technology, reimbursement and market risk, regulatory and the latest financing risk.
arazy-group

Medical Device Consultants | Medical Devices Experts | Medical Lab Equipment - 0 views

arazygroup.blogspot.com

Medical Device Consultant registration Equipment regulatory

shared by arazy-group on 08 Sep 11 - No Cached
  • arazy-group on 08 Sep 11
     
    Arazy Group expertise is regulatory affairs and quality assurance for the medical device industry. We specialize in marketing safe and effective Medical Technology to international markets. Our experienced consultants are responsible for the successful registration of thousands of medical devices globally. Our customized solutions accommodate all stages of medical device's life cycle and our adaptable services fit any application and any size organization.
arazy-group

Arazy Group Demonstrating the Effectiveness of Products - 0 views

arazygroup.blogspot.com/...monstrating-effectiveness.html

lab equipments Medical Products

shared by arazy-group on 08 Sep 11 - No Cached
  • arazy-group on 08 Sep 11
     
    A large number of medical device companies take help from Arazy Group to make their product  appeal to potential markets. To make any product appeal to potential market, it is very important to check its safety and effectiveness. Arazy Group is one of the chief medical device consultants which have been helping innumerable medical device companies in this regard.
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

Medical Software Validation | Medical Device Software Validation | Medical Device Desig... - 0 views

www.arazygroup.com/SoftwareValidation

medical software validation device design devices regulatory designated agent listing FDA

shared by arazy-group on 07 Jul 11 - No Cached
  • arazy-group on 07 Jul 11
     
    Arazy Group has been assisting medical device companies to a large extent in the launch of their products and equipment at a global level.
  • arazy-group on 22 Sep 11
     
    Arazy Group is one of the leading global names 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 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 Russia - 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
     
    For a successful registration of medical devices in Russia, you can take help from the professional consultants of Arazy Group. 
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