Group items tagged certification - 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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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Arazy Group | Medes | MDC | FDA certification - 0 views

youtu.be/j-7S55pFkF4

device validation FDA certification medical registration

shared by arazy-group on 07 Sep 11 - No Cached

arazy-group on 07 Sep 11

http://www.www.arazygroup.com/US-FDA-Agent - Medical device validation, FDA certification, CE Mark clearance, and regional medical device registration and global authorized representatives.

<div class="cArrow"> </div><div class="cContentInner"><a href="http://www.www.arazygroup.com/US-FDA-Agent" rel="nofollow" target="_blank">http://www.www.arazygroup.com/US-FDA-Agent</a> - Medical device validation, FDA certification, CE Mark clearance, and regional medical device registration and global authorized representatives.</div>

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EU Certificate of Free Sales (CFS) | Medical Device Consultants - 0 views

www.arazygroup.com/SaleCertificates

Medical Device Registration Consultants Approval Regulatory

shared by arazy-group on 29 Jul 11 - No Cached

arazy-group on 29 Jul 11

For medical devices cleared for sale with the USA - FDA, a Certificate for Foreign Governments (CFG) can be issued instead of a CFS.

<div class="cArrow"> </div><div class="cContentInner">For medical devices cleared for sale with the USA - FDA, a Certificate for Foreign Governments (CFG) can be issued instead of a CFS.</div>

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Technical File Preparation | CE Mark Certification | Medical Device Regulation | CE Mar... - 0 views

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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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

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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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IVD | GMP Certificates| Medical Device Manufactures | Vitro Diagnostics Products | Audi... - 0 views

arazy-group on 22 Sep 11

Foreign and local medical device manufacturers are now required to be inspected and be in compliance with the Brazilian Good Manufacturing Practices requirements prior to the submission of their devices for registration with ANVISA, the Brazilian authority in charge of the medical devices and IVDs clearance.

<div class="cArrow"> </div><div class="cContentInner">Foreign and local medical device manufacturers are now required to be inspected and be in compliance with the Brazilian Good Manufacturing Practices requirements prior to the submission of their devices for registration with ANVISA, the Brazilian authority in charge of the medical devices and IVDs clearance.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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Medical Device Registration in Brazil | Brazil Medical Device Consulting - 0 views

arazygroup.com/device_registration_in_brazil_

Medical Device Registration Consultants Consulting Expert

shared by arazy-group on 25 Jul 11 - No Cached

arazy-group on 25 Jul 11

Find qualified consultants for the Brazil medical device industry at arazygroup.com Medical Device specific regulation strategy reports, Medical Device Registration with ANVISA, Brazilian Representative and certification holder for Medical Device man.

<div class="cArrow"> </div><div class="cContentInner">Find qualified consultants for the Brazil medical device industry at arazygroup.com Medical Device specific regulation strategy reports, Medical Device Registration with ANVISA, Brazilian Representative and certification holder for Medical Device man.</div>

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US FDA Clearance | Medical Device Safety compliance - 0 views

arazygroup.com/USFDAclearance

us fda clearance approval regulations process standards vs device

shared by arazy-group on 25 Jul 11 - No Cached

arazy-group on 25 Jul 11

us fda clearance us fda approval, fda approval, fda regulations, fda approval process, fda standards, fda clearance vs approval, us fda certification.

<div class="cArrow"> </div><div class="cContentInner">us fda clearance us fda approval, fda approval, fda regulations, fda approval process, fda standards, fda clearance vs approval, us fda certification.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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Medical Device Consultants in Brazil | Medical Device Safety compliance - 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 expertise in medical device consultation and clinical literature review services in Brazil. We are the market leaders in gaining verification, validation and certification for different medical device manufacturers and marketers.

<div class="cArrow"> </div><div class="cContentInner">Arazy Group offer expertise in medical device consultation and clinical literature review services in Brazil. We are the market leaders in gaining verification, validation and certification for different medical device manufacturers and marketers.</div>

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Essential Requirements | Medical Device | FDA |Regulatory Designated Agent | FDA Device... - 0 views

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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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Medical Device Services South Africa| Medical Devices |Medical Device Registration Sout... - 0 views

www.arazygroup.com/southfrica

medical device services South Africa devices registration FDA regulatory requirements listing diagnostic industry CE mark consultancy

shared by arazy-group on 22 Sep 11 - No Cached

arazy-group on 22 Sep 11

Arazy Group, a Universal medical device consultant, offers medical device verification, validation as well as certification services in South Africa.

<div class="cArrow"> </div><div class="cContentInner">Arazy Group, a Universal medical device consultant, offers medical device verification, validation as well as certification services in South Africa.</div>

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Quality System Audits | Medical Device | IVD Equipment | CE Mark | QMS Activities | FDA... - 0 views

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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">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.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.</div>

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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.

<div class="cArrow"> </div><div class="cContentInner">We invite you to join Arazy Group Medical Device Consultants to share your knowledge with us and get paid (well) for your contribution.</div>

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Group items tagged

EU Certificate | EU Certificate of Free Sales| CFS | FDA | EU Health Authority | Medica... - 0 views

EU Health Authority | Medical Device Authority | Medical Device Service |EU Certificate... - 0 views

Arazy Group | Medes | MDC | FDA certification - 0 views

EU Certificate of Free Sales (CFS) | Medical Device Consultants - 0 views

Technical File Preparation | CE Mark Certification | Medical Device Regulation | CE Mar... - 0 views

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

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

IVD | GMP Certificates| Medical Device Manufactures | Vitro Diagnostics Products | Audi... - 0 views

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

Medical Device Registration in Brazil | Brazil Medical Device Consulting - 0 views

US FDA Clearance | Medical Device Safety compliance - 0 views

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

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

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

Essential Requirements | Medical Device | FDA |Regulatory Designated Agent | FDA Device... - 0 views

Medical Device Services South Africa| Medical Devices |Medical Device Registration Sout... - 0 views

Quality System Audits | Medical Device | IVD Equipment | CE Mark | QMS Activities | FDA... - 0 views

FDA 510 | FDA US Agents | FDA Device Listing | FDA US Agents | FDA Registration US | FD... - 0 views

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

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

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