Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are ...

As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming ...

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving ...

Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, ...

The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these ...

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional ...

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How ...

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports.

Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete?

Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency. Attention: If you are a medical device company and you have class II or class III ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S.