Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Explore how enterprise-grade EHR integration services accelerate medical device innovation by enabling seamless data exchange ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...