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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.

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.

Any company that wants to manufacture or import medical devices in Argentina must have a Quality Management System in compliance with ANMAT's GMP. ANMAT GMP QMS System Implementation, Anmat GMP QMS System Implementation.

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.

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.

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.

for any assistance you may need for the preparation or implementation of GMPs. We also provide step by step guidance, external auditing, online consulting and fully outsourced quality assurance maintenance services for your organization.

Medical Device specific regulation strategy reports, Medical Device Registration with PMDA, Japan Health Technical documents Preparation, Japan Market Authorized Holder and local Representative (MAH), Japan GMP compliance and Arazy Group's unique line of GlobaR - Global Regulatory Hub™ products.