A AD Sistemas can help your company comply with the medical Quality Management System for Brazilian National Health Vigilance Agency (Agência Nacional de Vigilância Sanitária – ANVISA), Union European and other regulatory agencies, executing the services:

• definition of policies, processes and procedures required for planning and execution in their business area of an organization for the certification complying the Good Manufacturing Practice (GMP - ANVISA), ISO 13485 e MDD 93/42 (CE Mark), ISO 9001, and others;
  
  
• training staff;
  
  
• implementation e auditing the Medical Quality Management System.

  Standards:

• RDC 059:2000 – Boas práticas de fabricação de produtos médicos (Good Manufacture Practice of Medical Devices);
• ISO 13485:2003 – Medical Devices – Quality Management System – Requirements for regulatory purposes;
• ISO 9001:2000 – Quality Management System – Requirements.
• MDD 93/42/EEC – Directive Medical Devices – CE Mark.
• And anothers harmonised standards.