AI-Enabled Medical Device Regulatory and Human Factors Consulting

Regulatory and Human Factors support for AI-enabled medical technologies

Artificial intelligence is reshaping medical technology, from hardware with embedded AI and software in a medical device (SiMD) to software as a medical device (SaMD) powered by machine learning. Emergo by UL helps manufacturers address the regulatory, quality and human factors considerations associated with these technologies. Our specialists support medical device software (MDSW), AI-enabled device software functions and other healthcare software intended for regulated use, from early product definition and market research through submission, launch and post-market surveillance.

We also support regulatory and quality teams using AI to accelerate research, documentation and submission processes. Our experts provide human-in-the-loop review to identify gaps, verify content against source evidence and applicable requirements, and strengthen documentation before it moves forward.

Global market access for AI-enabled medical devices and SaMD

AI-enabled medical devices can create regulatory complexity because the product, algorithm, data, intended users and operating environment may evolve together. Our medical device market access consultants help manufacturers develop global regulatory strategies for medical device hardware with embedded AI, SaMD, SiMD and other MDSW.

Depending on the product and target markets, our support may include intended-use and classification assessments, regulatory pathway and market-entry planning, gap analyses, pre-submission strategy, technical documentation, quality management system (QMS) alignment, software life cycle and risk-management documentation, clinical and performance evidence planning, labeling, registration, and post-market compliance. We help manufacturers communicate what the device does, who it is for, how AI contributes to its medical purpose, what evidence supports its performance and how foreseeable risks are controlled.

Manufacturers are also using generative AI and other AI tools for regulatory intelligence, literature reviews, templates, QMS documents and draft submission content. Emergo can review AI-assisted materials against source evidence, applicable requirements and the manufacturer’s quality processes. We help identify unsupported, inconsistent or missing content and refine draft inputs into traceable, submission-ready documentation. This human-in-the-loop approach allows teams to benefit from AI-enabled efficiency while maintaining accountable regulatory judgment.

Our consultants can also help manufacturers address life cycle considerations for AI-enabled products, including model updates, versioning, change control, monitoring, post-market surveillance and, where applicable, predetermined change control plans.

Human factors supporting the safety and effectiveness of human-AI interaction

For AI-enabled medical technologies, usability involves more than making a screen easy to navigate. Patients, caregivers and healthcare professionals may need to understand the meaning, limitations and appropriate next steps associated with an AI-generated output.

Our human factors specialists employ user-centered design and human factors engineering methods to study how people interact with AI-enabled devices and software in realistic contexts of use. We can support user research, task analysis, use-related risk analysis, user-interface and information-design evaluation, formative studies, usability testing, and validation planning.

Our research can examine human-AI interaction considerations such as automation bias, overreliance, underreliance, alert fatigue, explainability, transparency, uncertainty communication, error recovery and workflow integration. These insights help manufacturers determine whether users can notice, interpret and act on AI outputs appropriately, recognize when an output may not apply, and understand when independent judgment or additional information is needed.

Findings can inform user-interface requirements, risk controls, labeling, instructions for use, training and the human factors evidence included in a regulatory submission. The objective is to make the product’s capabilities and limitations clear enough to support safe and effective use.

Connect regulatory strategy with real-world use

AI-enabled healthcare technologies requires more than algorithm performance. Product claims, supporting evidence, quality controls, regulatory strategy and the user experience must tell a consistent story.

Emergo brings medical market access and human factors perspectives together to help manufacturers identify gaps earlier, align submission documentation with user needs and communicate AI-enabled functionality clearly. Whether you are developing an AI-enabled device, expanding an existing product into new markets or using AI within regulatory and quality workflows, our experts can help define the practical path forward.

Connect now with Emergo’s team of medical device experts for training, strategic discussions, regulatory or user design questions around artificial intelligence.