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

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    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

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    Arazy Group Universal Authorized Representative™ service takes away this burden and eliminates the need for multi legal contracts and different foreign currencies.
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    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.
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    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.
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    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.
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    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.
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Medical Device Consultants in Turkey | Medical Device Registration - 0 views

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    Arazy Group offer quality and vital medical device consultation for ensuring market clearance and meeting quality standards in the medical device industry in Turkey.
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Medical device registration Oman | Medical Device Consultants Oman - 0 views

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    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.
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    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.
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medical device consultants , ISO13485 Quality Management System - 0 views

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    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

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

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    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.
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Canadian Medical Devices Conformity | CMDCAS Canadian Medical Device Conformity - 0 views

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

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

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

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

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    Arazy Group is a leading name in regulatory affairs and quality assurance in the medical device industry in Argentina.
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Medical Device Consultants in Columbia | Medical Device Registration - 0 views

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    Arazy Group is a leading global medical device regulatory and consulting firm offering localized and standard quality services in Columbia as well.
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Medical Device Consultants in Israel | Medical Device Safety compliance - 0 views

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    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.
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Regulatory Dossier Preparation | Medical Device Safety Compliance | Medical Device Regu... - 0 views

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    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.
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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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SOP | Clean Room procedures | Medical Devices| Manufacture of Medical Devices | Special... - 0 views

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    Arazy Group Bank of SOPs includes procedures for most of the manufacturing processes practiced in the MedTech industry under various environmental conditions.
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21CFR 820 | FDA QSR | cGMP -FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device C... - 0 views

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

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    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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