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

Análise inicial dos processos, requisitos e controlos da empresa

Training

Formação e consciencialização dos responsáveis pelas áreas críticas

Workshops & Follow-ups

Para implementação e manutenção do Sistema de Gestão

Process Monitoring & Review

Preparação para a auditoria de certificação

Certification

Auditoria externa realizada por auditor independente

Benefits

What are the benefits for your company?

Progress

Creating a solid foundation for growth and expansion of operations into new markets

Monetization

Reduced waste, rework and other inefficiencies

Efficiency

Process optimization makes organizations more efficient

Trust

Delivery of safe medical devices that meet customer requirements

ebook medical devices iso 13485

Learn how to improve the quality management system in medical devices.

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