ISO 13485
ISO 13485 is a standard that represents a set of quality management system requirements for any company involved in the design, production, installation, maintenance and manufacture of medical devices.
The purpose of these requirements is to ensure that medical devices and services meet customer expectations and relevant regulatory requirements.
Why implement it?
- Adoption of an adequate model for the implementation, monitoring and revision of all personal identity information in the Quality Management System;
- Prove software compliance with legal and regulatory requirements, as well as the needs of customers and end users;
- Ensure the effectiveness and safety of both the processes and the products delivered.
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- Identify risks in your work environment
- Organize and systematize tasks
- Guide and empower your team
ISO 13485 includes requirements for design and development, risk management, production and post-production processes for medical device companies.
How we perform.
Benefits
What are the benefits for your company?
Progresso
Criação de base sólida para o crescimento e expansão de operações para novos mercados
Rentabilização
Redução de desperdício, retrabalho e outras ineficiências
Eficiência
Otimização de processos trona as organizações mais eficientes
Trust
Entrega de dispositivos médicos seguros que atendem aos requisitos do cliente