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.
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 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
External audit carried out by an independent auditor