Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive ...

The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

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 ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

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, ...

In a year characterized by both unprecedented challenges and groundbreaking advancements, the medtech industry continues to demonstrate its resilience and capacity for innovation. Faced with the ...

Growing up in a family deeply rooted in medicine, I had a unique perspective on the field. My grandparents attended Meharry Medical College, and my parents met while studying at Howard University ...

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 ...

Pressures on healthcare systems are set to become worse with aging populations requiring round-the-clock care and an exponential increase in chronic diseases. Technology-led smart solutions are ...