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

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

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

Catastrophic failures rarely stem from isolated hardware bugs. They breed where hardware, firmware, wireless telemetry, and ...

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

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

MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts ...

Patient adherence has historically been a challenge. Patients may deviate from treatment plans due to a variety of factors, including lifestyle choices, technological complexity or just plain ...

Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies.

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning ...

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.

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...