BSI has surpassed 125 AI expert reviews conducted under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), marking a significant milestone in its assessment of safe, effective, and trustworthy artificial intelligence (AI) in healthcare.
This achievement comes as BSI celebrates 125 years of helping organizations build trust, improve performance, and support innovation through standards, assurance, and regulatory expertise.
Over the past several years, BSI’s multidisciplinary team of AI specialists, medical device experts, clinicians, and regulatory professionals has conducted AI expert reviews across a wide range of healthcare applications, including medical imaging, diagnostics, treatment planning, screening, clinical decision support, and patient monitoring. Through these reviews, BSI has helped manufacturers navigate complex regulatory requirements while supporting patient safety and clinical effectiveness.
Omkar Joshi, Managing Director, AI & Digital Solutions, BSI, said: “Reaching more than 125 AI expert reviews demonstrates both the rapid growth of AI-enabled medical technologies and the increasing demand for independent assessment of AI systems. As artificial intelligence becomes more deeply integrated into healthcare, manufacturers are seeking trusted Certification Bodies and Notified Bodies that can help them bring innovative solutions to market responsibly and in compliance with evolving regulatory requirements.”
“As we mark our 125th anniversary, this milestone reflects our long-standing purpose: helping organizations build trust in new technologies. From supporting quality and safety in traditional industries to helping shape confidence in AI-enabled healthcare, we continue to work alongside innovators to help ensure technological progress delivers positive outcomes for society.”
The breadth of technologies reviewed by BSI’s AI experts demonstrates the transformative impact AI is having across healthcare, including:
Circle Cardiovascular Imaging
Circle Cardiovascular Imaging is a global leader in advanced cardiac imaging software, providing clinicians with sophisticated tools to analyse cardiovascular MRI and CT scans. Its AI-enabled technologies help healthcare professionals derive faster and more consistent insights from complex imaging data, supporting the diagnosis and management of cardiovascular disease.
Through AI-assisted image analysis and workflow optimization, Circle Cardiovascular Imaging is helping clinicians improve efficiency while maintaining confidence in clinical decision-making.
“BSI conducted a thorough AI-focused review of our CVI42, TruPlan and StrokeSENS software applications evaluating model validation, risk controls, and lifecycle documentation against relevant standards and regulations. Their team combined strong technical expertise with clear regulatory insight that strengthened our technical file and submission readiness. BSI was professional, responsive, and a pleasure to work with throughout.” Dr. Shirantha Samarappuli VP – Regulatory Affairs and QMS
Apneal
Mitral’s Apneal solution is helping to transform the diagnosis of sleep apnoea using artificial intelligence and smartphone-based technology. Designed to make diagnosis and screening more accessible and convenient, Apneal enables patients to undergo assessment using technology that is already widely available, reducing barriers associated with traditional sleep studies.
The solution demonstrates how AI can be applied to address significant unmet healthcare needs by supporting earlier identification of sleep disorders and helping improve access to diagnosis. As demand for scalable, patient-centric healthcare solutions continues to grow, innovations such as Apneal illustrate the potential for AI-enabled medical devices to expand access to care while maintaining clinical confidence and regulatory compliance.
“Apneal democratizes sleep apnoea diagnosis by bringing reliable, clinical-grade capabilities directly to a patient’s smartphone. BSI’s rigorous AI review and certification process provided the crucial validation we needed, helping ensure our AI-enabled diagnostic software as a medical device balances rapid innovation with high standards of patient safety and regulatory compliance.” Séverin Benizri, CEO, Mitral
Tonic Easy Medical
Tonic Easy Medical represents an emerging generation of medical device software that incorporates large language model (LLM) technology within healthcare workflows. As one of the relatively few medical device manufacturers to successfully implement LLM capabilities within a regulated product environment, Tonic Easy Medical demonstrates how generative AI can be applied responsibly in healthcare.
Its approach highlights both the opportunities and challenges associated with deploying advanced AI technologies while maintaining compliance, transparency, and patient safety.
Tonic Easy Medical supports more than 200,000 registered physicians across France, Italy, Spain, and Portugal, and is among the fastest-growing clinical AI platforms in Europe. The company has also certified its AI management system to ISO/IEC 42001 with BSI.
"Working with BSI supported our transition into a more mature, scalable quality and compliance framework, aligned with both ISO 13485 and MDR requirements. BSI brought credibility, structure, and deep expertise, including in artificial intelligence. The audit process was rigorous but constructive, and it helped us strengthen our systems in a meaningful way." Cristiana Oliveira, Quality and Compliance Manager, Tonic Easy Medical
The milestone of more than 125 AI expert reviews highlights the accelerating adoption of artificial intelligence throughout healthcare and reinforces BSI’s commitment to supporting responsible innovation. With regulatory frameworks continuing to evolve, including the introduction of the EU AI Act and emerging regulatory updates under the AI Omnibus, BSI remains focused on helping manufacturers understand and meet emerging requirements while bringing safe, effective, and trustworthy technologies to patients and healthcare professionals.
For 125 years, organizations have relied on BSI to help build confidence in the products, services, and systems that shape everyday life. Today, that legacy continues through BSI’s work in AI assurance and medical device conformity assessment, supporting the next generation of healthcare innovation.
Discover more information about BSI’s AI expertise in medical devices.
