Critical Software Achieves ISO 13485 Certification
The ISO 13485 certification recognizes our compliance with rigorous, internationally recognized quality management standards.
Critical Software is pleased to announce that it is now an ISO 13485-certified company. This certification demonstrates the strength and robustness of its quality management system for medical device development.
Luís Coelho, Principal Engineer for the medical device industry at Critical Software, commented on the achievement:
“ISO 13485 is the best way to demonstrate our reliability and capability to develop medical devices. As a highly regulated market, our medical device clients trust us to consistently deliver quality in our projects, producing the evidence required for the medical device certification process.”
The ISO 13485 standard focuses not only on the quality management system—defining where and how these processes must be applied across the organization and accounting for the various roles involved—but also on implementing a risk-based approach to controlling the processes required for an effective quality management system.
In the medical device industry, where proper device performance can be a matter of life and death, it is essential that all roles involved in the development process align with the quality management system. This ensures reliable performance and supports continuous improvement. ISO 13485 certification highlights Critical Software’s capabilities in this area.
Explore our website for a comprehensive overview of our expertise as an ISO 13485-certified company, and discover why we stand out among organizations specializing in medical device development.