AI Enabled Medical Devices

Intertek provides tailored solutions that address AI data quality, algorithm transparency, and compliance with global regulatory frameworks.

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in medical devices is revolutionizing the healthcare industry. This transformative technology is reshaping the ways medical devices operate, offering enhanced diagnostic capabilities, personalized treatment plans, and improved patient outcomes. Rapid advancement of AI Enabled and Machine Learning medical devices is driven by technological innovations, market demands, and regulatory support worldwide.

AI has already been introduced across a variety of products and applications in the healthcare industry, such as:

Wearables
Healthcare assistance robots
Medical imaging and diagnostics
Emergency rooms and surgery
Drug Discovery
Virtual nursing assistants
Mental health
Inpatient care and hospital management
Patient data and risk analysis
Cybersecurity

Regulatory bodies are developing frameworks to ensure the safe and effective use of AI and ML in medical devices. The FDA in the United States, Health Canada, and the European Union are all being proactive in this area to ensure safety of patients and quality of devices.

Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices

Understanding the regulatory landscape and compliance requirements of Artificial Intelligence (AI) and Machine Learning (ML) in medical devices is essential for manufacturers to ensure the safety and effectiveness of these advanced devices.

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Artificial Intelligence (AI) and Machine Learning (ML) in medical devices fact sheet

Intertek leverages its extensive expertise in medical device technologies and regulatory requirements to support manufacturers in integrating AI and ML into their products. Our team of experienced professionals offers comprehensive testing, certification, and advisory services to ensure that your AI-enabled and Machine Learning medical devices meet the highest standards of safety, performance, and regulatory compliance.

We offer tailored solutions that address organizational support (QMS driven) as well as product compliance and regulatory guidance, aimed to align with global regulatory frameworks, including:

Good Machine Learning Practice (GMLP)
FDA's Pre-Certification Program
Predetermined Change Control Plan (PCCP),
European Union's AI Act

A sound, risk-based approach can ensure that AI applications are safe and reliable. Contact us today to learn more about how we can help you integrate AI and ML into your medical devices and achieve your business goals.