Insights
AI compliance agent reach exceptional accuracy on assessments
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.
AI compliance agent reach exceptional accuracy on assessments
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.
Why AI-native product development compresses the innovation cycle
AI-native product development places artificial intelligence at the centre of how products are conceived and built, rather than treating it as an addition to an established process. It shortens feedback cycles, integrates quality assurance into day-to-day development, and allows teams to evaluate a wide range of design options far more quickly than sequential methods allow. For organisations looking to increase development velocity, the shift represents a structural change in how product work is organised, not simply an upgrade to individual tools.
Agile hardware for medical devices: It’s not rocket science… unless it is!
Unique challenges of Agile hardware development and strategies to address those.
From Friction to Flow: Agile in Medical Hardware Development
A large, complex medical device product organization achieves a 75%
reduction in cycle time for developing solutions to defects found in the
field.
Driving Execution Excellence in a Hardware-only Medical Device Environment
A leading medical imaging device manufacturer developing hardware-only
products sought to improve execution performance across its 300-person-
strong engineering teams.
Building-in compliance in Agile product development
Strategies to make compliance work for your Agile teams.
