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 ...

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 ...

Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions — and as the administration plans a broader reorganization, the impact will likely grow. One ...

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 ...

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 ...

The medical device market in India is one of the best places for the world to tap into since the early 2000s. Many are watching the evolution of the medical device industry in India, with McKinsey and ...

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 ...

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully ...