Arazy Group

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.

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.

Arazy Group has been assisting medical device companies to a large extent in the launch of their products and equipment at a global level.

Arazy Group is one of the leading global names in medical software Validation offering a wide range of medical device regulatory services, medical device software and clinical literature review for medical device manufacturers and distributor around the world.

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

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 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.

Biocompatibility can be a complex process as many medical devices are made of more than one material. The current leading standard for biological evaluation of medical devices is ISO 10993 at its latest version.

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 is a leading global name in medical software Validation offering a wide range of medical device regulatory services, medical device software and clinical literature review for medical device manufacturers and distributor around the world.

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.

As an international company, we make sure we are available to our clients around the clock through various channels of communication in multiple languages.

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.

Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.

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 around the world.

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

MDR procedure describing a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance System.

Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.

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.

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.

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.

We invite you to join Arazy Group Medical Device Consultants to share your knowledge with us and get paid (well) for your contribution.

Medical device consultants are equipped with proficient tradesmen who would have the complete understanding in what it takes to introduce a new medical device in the market and that too, in a most competent, time effective and rationalized manner.