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 and awareness-raising of those responsible for critical areas

Workshops & Follow-ups

For the implementation and maintenance of the Management System

Process Monitoring & Review

Preparation for the certification audit


External audit conducted by an independent auditor


What are the benefits for your company?


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


Reduced waste, rework and other inefficiencies


Process optimization makes organizations more efficient


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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