Process AI in Medical Device: What Works and What’s Next

Research from QServe Group and TransPerfect Medical Device asked manufacturers how they are utilizing AI in their clinical and regulatory processes (Process AI).

Although 70% report not being fully satisfied with current outcomes, many manufacturers are unsure how to apply AI effectively in regulated environments.

This session will address that challenge by highlighting where Process AI is already delivering measurable value, such as in AI-supported translation and linguistic quality assurance workflows that improve consistency, accuracy and compliance.

Driven by the increased regulatory demands under MDR and IVDR, Process AI is being utilized or evaluated by over 48% of manufacturers surveyed across regulatory, clinical and training/education.

Yet challenges remain: large language models (LLMs) struggle with reproducibility, factual reliability and explainability.

Specialized techniques like scaling parameters, stacking reasoning layers or chaining agents haven’t solved these basic issues. The path forward lies not in chasing the newest model but in creating a development framework that allows the right model to be applied to each use case.

In this session, the featured speakers will first discuss where and how Process AI is working today through language workflows, translation and linguistic QA. These areas are where neural-engine training, human-in-the-loop review and real-time quality monitoring deliver measurable results, reducing translation cost time by 30-40% while maintaining traceability and compliance. LLMs can assist with terminology and QC, but their variability requires validated guardrails.

The webinar will also explore the use of Process AI across life sciences operations. Instead of treating each process, such as post-market surveillance, complaint handling, systematic literature review and regulatory content authoring, like separate AI projects, this session will show how the same core tasks (like classification, extraction, summarization and generation) can be mixed and matched. With these building blocks in place, attendees will be able to create reviewer-ready, compliant systems that can scale.

Register for this webinar to learn how Process AI enables scalable, compliant automation for medical device manufacturers.

Speakers

Marc Miller, Division President, TransPerfect Medical Device

Marc Miller has over 30 years of experience assisting all sizes of medical device manufacturers with translation and process automation for labelling, marketing, e-learning, software and other product-related content. He founded the first translation company certified to ISO 13485 and ISO 14971 and is a co-author of the industry’s only risk management patent. In addition, he developed the first content automation system specifically designed to meet MDR and IVDR content requirements. Marc holds a BA from Harvard University and an MBA from Stirling University (Scotland).

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Sepanta Fazaeli, Head of AI Solutions for Life Sciences, TransPerfect Life Sciences

Sepanta Fazaeli is Head of AI Solutions for Life Sciences at TransPerfect, where he leads the strategic design and implementation of purpose-built AI frameworks that modernize how life-science organizations manage data, content and workflows. His work focuses on transforming complex, regulated operations, such as evidence generation, regulatory authoring and post-market monitoring, into scalable, intelligent systems that are explainable, auditable and human-in-the-loop by design. With a background in bioengineering and clinical data science, Sepanta bridges domain expertise with AI and data architecture to create practical, trustworthy applications that accelerate innovation without compromising compliance. His approach centers on aligning people, processes and technology to help the life sciences industry move from isolated AI pilots to integrated, enterprise-scale intelligence.

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