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.
As AI becomes increasingly prevalent in healthcare, regulations and global standards serve as the essential framework ensuring patient safety, data integrity, and diagnostic accuracy.
Avicenna’s AI solutions are classified as medical devices, subject to strict rules covering design, development, validation, and post-market surveillance across every market in which we operate.
Avicenna holds active market clearances in more than 50 countries, with regulatory approvals across all major healthcare markets.
FDA clearance pathway for AI diagnostic devices
CE marking 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
Covers quality management for medical device manufacturers: design, development, production, installation, and servicing, with a focus on continuous improvement.
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.
Allows a single QMS audit to satisfy requirements of multiple regulatory authorities: TGA, ANVISA, Health Canada, and FDA.
Defines lifecycle requirements for medical device software, covering development, maintenance, and risk management throughout the software lifecycle.
Specifies requirements for the safety, effectiveness, and security of health software, particularly relevant for AI-based clinical decision support.
Governs the application of usability engineering to medical devices to ensure safe and effective use in clinical environments.
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.
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