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

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

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 ...

To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet ...

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 ...

The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, ...

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients – ...

In an era where sustainability is no longer a choice but a necessity, the medical industry finds itself at a crossroads. With the increasing amount of medical waste generated daily, the traditional ...