Critical Software Achieves ISO 13485 Certification

July 27, 2022

The certification recognises our compliance with rigorous, internationally recognised quality management standards.

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Critical Software is delighted to announce that it has received ISO 13485 (Medical Devices – Quality Management Systems) certification. The certification demonstrates the robustness of the quality management system for medical devices development.  

Luís Coelho, Principal Engineer for the medical devices industry at Critical, spoke of the achievement: “ISO 13485 is the best way to demonstrate our reliability and capability to develop medical devices. Being a highly regulated market, our medical devices clients trust us to always execute our projects with quality, producing evidences needed for the medical devices certification process.” 

ISO 13485 focuses not only on the quality management system, defining where these processes need to be applied throughout the organisation and accounting the various roles involved, but also on applying a risk-based approach to the control of the appropriate processes required for the quality management system.  

In the medical devices industry, where the proper functioning of the device can mean life-or-death for patients, it is vital that all roles involved in the development process are aligned with the quality management system, making sure that it works without fault and maintaining continuous improvement. ISO 13485 demonstrates Critical Software’s capabilities in this regard.