Group items tagged

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 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.

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 in Europe.

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.

Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.

Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.

Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent.

Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent. We have been serving hundreds of companies worldwide since the new FDA regulation came into force on April 2002.

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 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.

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.

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.

Clinical trials planning and design are based on the therapeutic principles, regulatory standards and guidance documents, background literature and labeling of equivalent products.