Celegence says AI plus automation halved the time to write post-market surveillance documents.

Device and diagnostic makers must produce heavy EU MDR post-market surveillance documentation. Celegence launched CAPTIS Copilot, a cloud platform using pre-trained LLMs and human-feedback tuning. The release states AI combined with traditional automation cut PMS documentation writing time in half and improved consistency.

Celegence is a regulatory affairs and medical writing firm with a generative AI platform, used for CMC submission drafting and medical device compliance documents

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.