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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ISO 13485 includes requirements for design and development, risk management, production and post-production processes for medical device companies.

How we perform.

Assessment of Normative Requirements

Initial analysis of the company's processes, requirements and controls

Training

Training and raising awareness of those responsible for critical areas

Workshops & Follow-ups

For implementation and maintenance of the Management System

Process Monitoring & Review

Preparation for the certification audit

Certification

External audit carried out by an independent auditor

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

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