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Europe Union | Medical Devices |IVD Devices | IVD| CE Mark Registration | Active Implan... - 0 views

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

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

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

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    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
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    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
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Sterilization Validation of Medical Devices | Medical Device Safety Compliance | Medica... - 0 views

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    Arazy Group offer complete third party lab services for medical device packaging and sterilization validation for any device and any risk classification.
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    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

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

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    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.
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    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 Device Registration in Israel| Medical Device Services | Medical Devices | Medi... - 0 views

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    Arazy Group helps you understand the required EU directives in relation to the medical device industry in North America. You can introduce your medical device, IVD or medical device equipment into the North America device industry with our expert help and assistance.
arazy-group

Medical Device Registration in Norway| Medical Device Services | Medical Devices | Medi... - 0 views

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    Arazy Group helps you understand the required EU directives in relation to the medical device industry in Norway. You can introduce your medical device, IVD or medical device equipment into the Norway medical device industry with our expert help and assistance.
arazy-group

Medical Device Design Africa| Medical Device Registration Africa| Medical Device Servic... - 0 views

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    Arazy Group helps you understand the required EU directives in relation to the medical device industry in South Africa. You can introduce your medical device, IVD or medical device equipment into the South African medical device industry with our expert help and assistance.
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FDA 510 | FDA US Agents | FDA Device Listing | FDA US Agents | FDA Registration US | FD... - 0 views

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    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

Medical Device Registration Australia | Medical Device Services | Medical Devices | Med... - 0 views

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    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.
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Arazy Group | Medes | MDC | Medical device consultants in USA - 0 views

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    http://www.arazygroup.com/medical_device_registration_in_usa_ - Medical device consultants in USA for FDA clearance services and fulfilling FDA requirements for medical devices, IVDs etc.
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Electromagnetic Compatibility (EMC), Medical device - 0 views

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

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    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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