Artificial intelligence (AI) continues to reshape the medical technology landscape—particularly in clinical evaluation, where automation and data analytics promise to save time and resources. However, as experts at the 2025 RAPS European Lifecycle Management Conference emphasized, AI should be viewed as a powerful assistant, not a replacement for human oversight.
AI’s Role in Clinical Evaluation
Panelists Andrew Gibson, Senior Managing Consultant at Akra Team, and Carole Robin, Head of the Clinical Department at Eurofins E&E France, discussed how AI tools can enhance efficiency during the clinical evaluation process.
Generative AI platforms like ChatGPT, Claude, and Elicit, as well as tailored solutions such as Flinn, DistillerSR, and CAPTIS, can automate critical steps—literature searches, screening, deduplication, data extraction, and summary generation. When used effectively, these tools can reduce manual workload by 60–80%, allowing researchers to focus on strategic review and interpretation rather than repetitive administrative tasks.
Robin noted that generative AI can refine search strategies and extract data efficiently, but verification remains essential. “It doesn’t reduce the need for verification,” she explained. “It shifts the effort.”
Balancing Generative and Tailored AI Tools
The experts highlighted that not all AI solutions are created equal. Generative AI excels at synthesizing information quickly but carries risks of hallucinations or inaccuracies. Tailored AI tools, designed specifically for clinical and regulatory applications, may offer greater reliability, consistency, and data security—though often at a higher cost and with more human input required.
According to Gibson, the decision to implement AI should depend on the organization’s size, portfolio complexity, and risk classification of its devices. Factors such as internal policies, workforce capability, and data protection practices also influence which AI tools are suitable.
Keeping Humans in the Loop
While AI has the potential to transform efficiency, both experts agreed that human oversight remains irreplaceable. Gibson cautioned against the notion of a “one-click” solution for clinical evaluation reports. “It defeats the process,” he said. “We need qualified and competent resources internally to assess the output of the AI in any of these cases.”
Human reviewers must oversee every stage—from protocol generation to literature inclusion/exclusion criteria, appraisal, and final report drafting. Even as AI capabilities improve, regulatory reviewers and clinical evaluators must be able to understand, verify, and defend the outputs. Accountability, the panelists emphasized, must always rest with human experts.
The Path Forward
As AI tools advance, their integration into medtech clinical evaluation processes appears inevitable. These technologies can dramatically shorten review timelines, improve traceability, and enhance accuracy—but only when paired with rigorous quality systems and human expertise.
Used responsibly, AI can strengthen compliance by ensuring faster, data-driven evaluations that still meet regulatory expectations for transparency and scientific validity. Ignoring such tools, as Gibson noted, means “missing out on a very powerful opportunity to optimize the process.”
At EMMA International
At EMMA International, we recognize that the future of regulatory science combines technology with human insight. Our experts help medical device and medtech organizations integrate advanced tools like AI into their clinical evaluation and quality management systems while maintaining compliance with FDA, EU MDR, and ISO 14155 requirements.
From process automation and documentation review to risk-based evaluation and technical report preparation, EMMA International provides strategic guidance to ensure your innovation remains both efficient and compliant.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Regulatory Affairs Professionals Society (RAPS). Experts: AI Tools Can Reduce the Clinical Evaluation Workload for MedTech Firms. (November 2025).
U.S. Food and Drug Administration. Artificial Intelligence and Machine Learning (AI/ML) in Medical Devices: Regulatory Considerations. (2025).
