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 ...

Per- and polyfluoroalkyl substances (PFAS), widely used in medical devices for their durability, biocompatibility, and resistance to temperature and moisture, are under growing scrutiny. Known as ...

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...

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 ...

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 ...

As a general matter, there are three common types of product liability claims: (1) manufacturing defect, (2) design defect, and (3) failure to warn. Each of these scenarios is premised upon a product ...

(KGMP) sets minimum standards with which medical device and In Vitro Diagnostics (IVD) device manufacturers must comply. It is one of the Quality Management System (QMS) standards that manufacturers ...

Human factors engineering (HFE), also known as usability engineering (UE), comprises the knowledge of human behavior, abilities, limitations, and other characteristics of medical device users that are ...

Healthcare is increasingly dependent on digital services and connected medical devices, leading to an increase in cyberattacks, primarily due to the value of data that can be obtained. Regulations ...