Regulations and global standards play a foundational role in today’s healthcare landscape, where patient safety, data security, and diagnostic accuracy are essential. As healthcare systems increasingly rely on advanced technologies, particularly artificial intelligence, robust regulatory frameworks are critical to ensuring trust, reliability, and clinical value.
At Avicenna.AI, our commitment to regulations and global standards reflects a clear priority: delivering AI-powered medical solutions that meet the highest expectations for safety, performance, and quality. Compliance is not treated as a constraint, but as a cornerstone of responsible innovation and long-term credibility in healthcare.
This commitment extends beyond regulatory approval alone. It encompasses patient health and well-being, the integrity of medical decision-making, and the seamless integration of AI technology into clinical workflows to drive meaningful and positive change worldwide.
As our AI solutions are classified as medical devices, they are subject to strict regulations and global standards governing their design, development, validation, and post-market surveillance. Through rigorous certification processes, we have obtained the necessary approvals to market and sell our products in more than 50 countries across the globe. These certifications reflect our ability to meet diverse regulatory requirements while maintaining consistent quality and performance.
Understanding regulations and global standards is essential for maintaining trust among healthcare professionals, institutions, and partners. Our adherence ensures alignment with international expectations and reinforces our credibility as a reliable medical AI provider. To remain fully compliant, we continuously monitor regulatory developments and evolving global standards, proactively adapting our processes to stay ahead of changes.
Our internal processes are designed to align with regulations and global standards at every stage of the product lifecycle, ensuring consistent quality outcomes and regulatory readiness.
Within the European Union, regulations play a central role in governing medical software. Software used for diagnostic and triage purposes is classified as a medical device and must comply with the European Medical Device Regulation (EU) 2017/745 (MDR). In line with these regulations and global standards, all our tools comply with the Medical Device Regulation (MDR).
To ensure continuous alignment with European regulations and global standards, Avicenna.AI has appointed a dedicated Person Responsible for Regulatory Compliance (PRRC). This role is currently fulfilled by our Regulatory Manager, Stephane Berger, ensuring ongoing oversight, accountability, and regulatory continuity.
Beyond Europe, our commitment to regulations and global standards extends internationally. Our products have obtained the required certifications for use in key markets including the United States, the United Kingdom, Canada, Brazil, Australia, and additional regions worldwide. For specific information regarding product registration in your country or the identification of an authorized representative, our team remains available to assist.
In addition to regulatory compliance, we strive to consistently meet and exceed recognized global standards. Regulatory authorities frequently acknowledge ISO (international) and EN (European) standards as validated benchmarks for demonstrating compliance. When recognized by legislative bodies, adherence to these standards supports conformity with specific regulatory requirements.
ISO 13485:2016 defines quality management system requirements for medical device manufacturers, covering design, development, production, installation, resource management, measurement, and continuous improvement. Our adherence to ISO 13485:2016 ensures that our products meet the highest quality expectations within the medical device industry.
Medical Device Single Audit Program (MDSAP) streamlines regulatory audits by allowing a single quality management system audit to satisfy the requirements of multiple regulatory authorities. These include the Australian Therapeutic Goods Administration (TGA), Brazil’s ANVISA, Health Canada, Japan’s MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). Participation in MDSAP reinforces our alignment with regulations and global standards across multiple jurisdictions.
Our commitment to regulations and global standards drives innovation and excellence in our products. Beyond ISO 13485 and MDSAP, our company and products conform to a range of standards indispensable for securing the CE marking of medical devices. These encompass:
Together, these regulations and global standards form the foundation of our approach to compliant, safe, and high-performing medical AI solutions.
If you have any queries or need further insight into our compliance practices, please don’t hesitate to reach out. For more information on our compliance with regulations and global standards, please contact us.
