Global Certifications
Compliance is not a burden, it is the foundation of responsible innovation in healthcare. Avicenna.AI’s regulatory programme spans global markets, ensuring our AI solutions meet the highest local and international standards.
Our Approach
FDA clearance pathway for AI diagnostic devices
FDA clearance pathway for AI diagnostic devices
UK authorized for post-Brexit medical device approval
Health Canada medical device licence Class 3 MDALL licence
ANVISA regulatory approval
TGA (Therapeutic Goods Administration) registration
Global presence
Avicenna holds active market clearances in more than 50 countries, with regulatory approvals across all major healthcare markets.
Standards compliance
ISO 13485
Covers quality management for medical device manufacturers: design, development, production, installation, and servicing, with a focus on continuous improvement.
ISO 14971
International standard for the application of risk management to medical devices, from identification through evaluation and control of risks to Medical devices embedding Machine Learning.
MDSAP
Allows a single QMS audit to satisfy requirements of multiple regulatory authorities: TGA, ANVISA, Health Canada, and FDA.
IEC 62304
Defines lifecycle requirements for medical device software, covering development, maintenance, and risk management throughout the software lifecycle.
IEC 82304-1
Specifies requirements for the safety, effectiveness, and security of health software, particularly relevant for AI-based clinical decision support.
IEC 62366-1
Governs the application of usability engineering to medical devices to ensure safe and effective use in clinical environments.
Your point of contact
As our appointed PRRC, Stéphane oversees regulatory compliance across all EU and global markets, ensuring Avicenna meets its obligations under MDR 2017/745 and international standards.
Stéphane Berger