Quality Management System
Our commitment to quality and strict compliance with legal requirements is assured through a robust Quality Management System (QMS), certified based on ISO 9001:2015 and on ISO 13485:2016. The adoption of this QMS is a strategic decision by the organisation and aims to improve our overall performance and provide a solid basis for sustainable development.
Quality Framework
(ISO 9001)
This ensures our capacity to supply products and services in a consistent manner, complying with legal and regulatory requirements, focussed on the customer and on continuous improvement.
Manufacture of Medical Devices (ISO 13485)
This defines the requirements for developing and supplying medical devices, guaranteeing regulatory conformity, safety and quality throughout the entire life cycle.
Our system is continuously improving through monitoring, measuring, data analysis and internal audits, thereby ensuring the ongoing relevance, suitability and effectiveness of the QMS, as well as the safety and performance of the medical devices.