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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.

Arazy Group experts can write the clinical literature review for your product based on the existing publications and your clinical studies while complying with both the international harmonized standards and the national guidelines.

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.

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.