We are proud to announce that Thirona has successfully renewed its ISO 13485 and EU MDR certifications and, for the first time, achieved certification under the Medical Device Single Audit Program (MDSAP) - a major milestone in strengthening our global regulatory foundation.

The ISO 13485 certification, an internationally recognized standard for quality management systems (QMS) in the medical device industry, confirms the strength and consistency of our internal processes across product development, clinical validation, and post-market support. This QMS also forms the backbone for meeting requirements under both MDR and MDSAP frameworks.

Thirona’s EU MDR certificate assures compliance with the European Union’s regulation for medical devices, especially in the areas of clinical evidence, safety, and ongoing surveillance. This applies to our flagship software products LungQ®.

Achieving initial MDSAP certification adds yet another layer of trust, while allowing Thirona to meet regulatory requirements in multiple global markets, including the United States, Canada, Australia, Japan, and Brazil, through a single, harmonized audit. MDSAP is a growing requirement among international partners and healthcare regulators.

The issuance of all three certificates is a clear reflection of Thirona’s ongoing commitment to excellence in quality and compliance. It reflects not only the strength of our quality and regulatory teams, but the collaborative effort across the entire organization. In the medical sector, maintaining compliance with evolving international regulations requires a deeply integrated approach, from R&D and clinical validation to software engineering, product management, and post-market support. Every discipline plays an important role in upholding the safety, performance, and traceability standards that these certifications represent.

At Thirona, compliance is not the responsibility of a single department. It is embedded in how we innovate, document, deliver, and support our solutions for partners and patients worldwide.