Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration ...

Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of ...

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

Recent U.S. elections and President Donald Trump’s new appointments have drawn global attention. Entire industries and nations brace for potential changes in their trade relationships with the world’s ...

The issue of misuse of medical devices is a major one. Whether it happens by patients using a device at home without proper training or by surgical staff looking for a faster way to operate a device, ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

With a population surpassing 44 million, Argentina presents a compelling proposition for medtech clinical trials, bolstered by its robust healthcare system, modern facilities, and a cadre of ...