C-mo Medical Solutions, a leading provider of next-generation cough-monitoring technology, is pleased to announce that it has received ISO 13485:2016 certification. This internationally recognised certification demonstrates that the company meets the stringent regulatory requirements for the design, development, manufacturing, distribution, and servicing of its medical devices.
“ISO 13485 certification is a foundational milestone for us,” said Diogo Tecelão, chief executive officer of C-mo Medical Solutions. “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 high-quality, regulatory-grade cough monitoring solutions.”
C-mo’s flagship technology provides a comprehensive, objective, and privacy-preserving solution for cough monitoring – enabling pharma, CROs, researchers, and healthcare providers to track and analyse the multiple dimensions of cough with clinical precision. This certification comes as the company 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,” said Chris Bergstrom, chairman of the board at C-mo Medical Solutions. “This achievement underscores C-mo’s readiness to serve regulated markets and support pharmaceutical 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 how cough is understood, measured, and managed.
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