An AI-based dual-agent system assessed Design controls and IEC 62304 compliance documents with 97.5% expert-validated accuracy and repeatability ranging from 99.8% to 100%. For quality teams still working through compliance assessments manually, the results show what a more consistent and auditable approach could look like.

A large, complex medical device product organization achieves a 75%
reduction in cycle time for developing solutions to defects found in the
field.

A leading medical imaging device manufacturer developing hardware-only
products sought to improve execution performance across its 300-person-
strong engineering teams.