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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

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.
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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

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

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 19 Jul 11 - No Cached
  • arazy-group on 19 Jul 11
     
    Arazy Group offer quality and vital medical device consultation for ensuring market clearance and meeting quality standards in the medical device industry in Turkey.
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 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

Medical Devices Experts, Quality Medical Devices - 0 views

arazygroup.com

Medical Device Consultants Devices Experts Lab Equipment Quality

shared by arazy-group on 06 Jul 11 - No Cached
  • arazy-group on 06 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

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

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 20 Jul 11 - No Cached
  • arazy-group on 20 Jul 11
     
    Singapore is a promising medical device market and welcomes manufacturers with new and quality medical technology to introduce their medical products in the Singaporean market.
arazy-group

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.
arazy-group

Medical Device Registration In Turkey | Medical Device Consultants Turkey - 0 views

arazygroup.com/device_registration_in_turkey_

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
     
    Arazy Group deals in regulatory affairs and quality assurance for the medical device industry. It offers offer registration of medical device services in Turkey. medical device registration in turkey, medical device consultants turkey, medical device.
arazy-group

Medical Device Approval Palestinian China | Medical Device Regulatory China - 0 views

arazygroup.com/_device_registration_in_china_

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
     
    Arazy Group deals in regulatory affairs and quality assurance for the medical device industry. It offers offer registration of medical device services in China. Medical Device specific regulation strategy reports, for more information, please submit..
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

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

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 19 Jul 11 - No Cached
  • arazy-group on 19 Jul 11
     
    Arazy Group is a leading name in regulatory affairs and quality assurance in the medical device industry in Argentina.
arazy-group

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

arazygroup.com/blog

Safety compliance device medical consultants devices

shared by arazy-group on 19 Jul 11 - No Cached
  • arazy-group on 19 Jul 11
     
    Arazy Group is a leading global medical device regulatory and consulting firm offering localized and standard quality services in Columbia as well.
arazy-group

Medical Device Consultants in Israel | Medical Device Safety compliance - 0 views

arazygroup.com/blog

Device Safety compliance medical consultants devices

shared by arazy-group on 19 Jul 11 - No Cached
  • arazy-group on 19 Jul 11
     
    Arazy Group offer quality and professional medical device registration services and work towards gaining validation, verification and market clearance for medical device and equipment manufacturers in Israel.
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

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

21CFR 820 | FDA QSR | cGMP -FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device C... - 0 views

www.arazygroup.com/FDA-QSR-GMP

21CFR 820 FDA QSR cGMP -FDA GMP Audits to 21 CFR Part for Device Companies packaging medical devices assembling

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have enacted that pharmaceutical and medical device companies must follow GMP procedures and have their own criteria that correspond with their legislations.
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.
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