Our Quality & Compliance Philosophy
At Thirona, quality, compliance and data protection are the foundation of how we design, validate and deliver our AI software solutions for lung image analysis.
Meeting the highest international standards for safety, performance, and data protection, we ensure every measurement is reliable, every process traceable, and every patient’s data secure.
Thirona’s Quality & Regulatory system is built for continuous improvement- audited, certified, and refined through collaboration with our MedTech and pharma partners worldwide. Because behind every analysis lies a patient, and behind every partnership, our promise of trust.
What our culture of quality means in practice:
Focus on Clinical Impact
Security by Design
Regulatory Compliance
Risk Management
Medical Data Security
Continuous Improvement
Compliant with the Highest Global Standards
Our software development processes are grounded in a certified Quality Management System (ISO 13485) and follow internationally recognized frameworks for medical-device software and data governance regulations, providing our partners with confidence in the integrity, confidentiality, and regulatory robustness of all operations.
Product Development & Regulatory Alignment
• EU MDR 2017/745
• U.S. FDA Quality System Regulation (21 CFR Part 820)
• IMDRF Software as a Medical Device (SaMD) guidelines
Information Security & Data Governance
• Certified to ISO/IEC 27001
• Aligned with FDA 21 CFR Part 11 for electronic records and data integrity
• Compliant with GDPR for secure and lawful handling of personal and medical data
A Trusted Legacy of Compliance and Quality
For more than a decade, Thirona has built trust in the medical industry through proactive quality and regulatory excellence.
From the first FDA clearance in 2018 to early MDR conformity, our proven commitment to quality and patient safety has consistently led the way toward the clinical adoption of AI.
- CE Marking under MDD LungQ® v1.x.y Class IIa
- ISO 13485 Certification
2016
- MDR Certification
- CE Marking under MDR LungQ® v2.y.z Class IIb
- ISO 27001 Certification
2022
- FDA 510(k) Clearance
LungQ® v3.0.0 Class II medical device - FDA 510(k) Clearance
LungQ® v3.1.0 Class II medical device
2024
2018
- FDA 510(k) Clearance LungQ® v1.1.0 Class II medical device
2023
- CE Marking under MDR LungQ® v3.y.z Class IIb
2025
- FDA 510(k) Clearnace
LungQ® v 3.y.z Class IIb - MDSAP Certification
- ISO 13485 & MDR Certification Renewal
- CE Marking under MDD LungQ® v1.x.y Class IIa
- ISO 13485 Certification
2016
- FDA 510(k) Clearance LungQ® v1.1.0 Class II medical device
2018
- MDR Certification
- CE Marking under MDR LungQ® v2.y.z Class IIb
- ISO 27001 Certification
2022
2023
- CE Marking under MDR LungQ® v3.y.z Class IIb
- FDA 510(k) Clearance
LungQ® v3.0.0 Class II medical device - FDA 510(k) Clearance
LungQ® v3.1.0 Class II medical device
2024
2025
- FDA 510(k) Clearnace
LungQ® v 3.y.z Class IIb - MDSAP Certification
- ISO 13485 & MDR Certification Renewal