C-mo Medical Solutions has been awarded ISO 13485:2016 certification. This internationally recognized certification signifies the company meets the stringent regulatory requirements for designing, developing, manufacturing, distributing, and servicing its medical devices.

“ISO 13485 certification is a foundational milestone for us,” C-mo Medical Solutions CEO Diogo Tecelão stated. “It reflects the high standards we’ve set in quality and compliance—and is a step forward in our mission to supporting clinical trials and medical practice with our regulatory-grade cough monitoring solutions.”

C-mo’s flagship technology provides a comprehensive, objective, and privacy-preserving solution for cough monitoring, enabling CROs, researchers, and healthcare providers to track and analyze the multiple dimensions of cough with clinical precision. The company received the certification as it prepares to launch its technology into the clinical trials market in the coming months.

“ISO 13485 certification is a key enabler for companies operating at the intersection of AI, technology, and clinical research,” C-mo Medical Solutions Board Chairman Chris Bergstrom said. “This achievement underscores C-mo’s readiness to serve regulated markets and support partners with real-world cough data that sets a new benchmark for quality and insight—meeting the growing demand across the industry.”

This certification aligns with the company’s goal to become the reference in cough assessment, bringing digital precision to respiratory endpoints and transforming the ways in which cough is understood, measured, and managed.

C-mo Medical Solutions is a medtech company developing solutions to improve care. Its mission is to unlock the clinical value of cough as a biomarker, addressing unmet needs in the monitoring and management of chronic cough. C-mo’s AI-powered biosensor and digital platform delivers the most comprehensive assessment of cough, enabling precise and clinically meaningful characterization of a patient’s respiratory health. It provides unobtrusive, long-term monitoring with reliability, and is the first solution to ensure privacy by not recording conversations. The company is backed by investors including Boehringer Ingelheim Venture Fund, High-Tech Gründerfonds, Novalis, and Portugal Ventures.