Skip to main content

Home/ Groups/ Arazy Group
Rss Feed
Sort By: Most Recent | Popular Filter: All | Bookmarks | Topics Simple Middle
arazy-group

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

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 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

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

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

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

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 | 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.
arazy-group

Usability Studies | FDA | Medical Device Design | FDA Medical Device | Medical Device R... - 0 views

www.arazygroup.com/UserabilityStudies

usability studies FDA medical device design regulations CE marking Consultants approval process mark EMC certification

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.
arazy-group

Clinical Evaluation through Literature Review | Clinical Literature Review |Medical Dev... - 0 views

www.arazygroup.com/ClnLiterRev

clinical evaluation through literature review medical device regulatory CE marking consultants approval

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 around the world.
arazy-group

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.
arazy-group

Medical Device Reporting | Devices | Device Vigilance System | FDA Agent | Medical Devi... - 0 views

www.arazygroup.com/VigilanceReport

reporting devices system FDA agent regulatory registration GMP compliance listing Medical Device Vigilance

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    MDR procedure describing a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance System.
  • arazy-group on 22 Sep 11
     
    Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.
arazy-group

Clinical Research Administration, High Quality Clinical Research | ISO 1348 | 510K Appr... - 0 views

www.arazygroup.com/ResearchAdministration

clinical research administration high quality ISO 1348 510 approval MDD 93 42 CE markings marking certification FDA medical device regulation

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    The Clinical Research Administrator facilitates the timely execution and completion of high-quality clinical research by assisting investigators and industry sponsors with all aspects of the clinical research.
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

FDA Consulting | FDA Consulting Privacy Policy | Medical Device Consultant| EMC Certifi... - 0 views

www.arazygroup.com/PrivacyPolicy

FDA consulting privacy policy medical device consultant EMC certification CE marking regulatory approval directive

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical device companies have faced regulatory, technological, reimbursement and market risks always. It can be said that these risks are not new, a new risk is added to the present set of challenges and that risk is called as financing risk.
arazy-group

Medical Device Industry| Expertise Regulatory Service| Medical Technology | Medical Dev... - 0 views

www.arazygroup.com/JoinExperts

medical device industry expertise regulatory service technology devices IVDD EMC certification

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    We invite you to join Arazy Group Medical Device Consultants to share your knowledge with us and get paid (well) for your contribution.
arazy-group

Expertise Regulatory Service| Medical Technology | Medical Device Industry| Medical Dev... - 0 views

www.arazygroup.com/IntroductionArazyGroup

expertise regulatory service medical technology device industry devices IVDD EMC certification

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical device consultants are equipped with proficient tradesmen who would have the complete understanding in what it takes to introduce a new medical device in the market and that too, in a most competent, time effective and rationalized manner.
‹ Previous 21 - 40 of 105 Next › Last »
Showing 20▼ items per page