ISO 13485

ISO 13485 medical software is the new achievement of CMG Swiss Sagl, which has successfully completed the first implementation of a Quality Management System compliant with ISO 13485:2016 for a software platform dedicated to wellness and health. This project marks an important step forward in the company’s ability to integrate certifiable standards within the medical and digital sector.

The objective of the initiative was to develop a management system capable of ensuring safety, reliability, and traceability across all stages of software development, maintenance, and release. ISO 13485 is the reference standard for medical devices and medical software, requiring strict control of quality processes and risk management.

The platform involved represents an advanced digital solution that enables the monitoring and optimization of physiological parameters and wellness pathways, featuring a cloud-based architecture and compliance with privacy, cybersecurity, and interoperability principles.

The system developed by CMG Swiss structured the entire software lifecycle in a methodical way, from clinical requirements analysis to validation and post-market management. The project included the definition of validation plans, non-conformity management, staff training, and the development of a quality manual fully aligned with ISO 13485 requirements.

As highlighted by Cindy Martine Grasso, CEO of CMG Swiss Sagl: “ISO 13485 represents a strategic milestone for companies operating at the intersection of technology and healthcare.” With this implementation, CMG Swiss strengthens its position in the healthtech sector, promoting integrated, secure systems oriented toward certified quality.