Leveraging AI in Regulatory Writing — Opportunities, Oversight & What Medical Device Leaders Need to Know

Artificial intelligence and large language models (LLMs) are transforming how medical device companies approach regulatory writing, but questions remain around how to implement these tools effectively and responsibly, and whether they actually save time and improve productivity. 

In this Ask the Expert session, the team at Criterion Edge will explore how AI and LLMs can be used to improve the speed, accuracy, and cost-efficiency of regulatory and clinical writing tasks, such as CERs, PERs, literature reviews, and clinical data summaries. We’ll also examine how AI supports submission consistency across global markets like the U.S. and EU. 

Learning Objectives  

• Understand how AI is being applied to accelerate regulatory writing workflows, including CERs, PERs, and PMAs.

• Explore how AI can improve the efficiency and accuracy of systematic literature reviews and clinical data summaries.

• Learn what global regulatory agencies expect when AI is used in authoring or supporting submission documents.

• Identify common risks and compliance considerations associated with AI-generated or AI-assisted content.

• Gain a framework for evaluating AI-enabled vendors or service providers for regulatory writing support.

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