With the regulatory changes facing the medical device industry, the European Union’s Medical Devices Coordination Group (MDCG) has published a position paper (MDCG 2022-11 Rev.1) aimed at ensuring that manufacturers and Notified Bodies are able to comply in a timely manner with the requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic […]

As technology advances, the use of Digital Health Technologies (DHTs) in clinical research is becoming more widespread.2023 In December 2023, the U.S. Food and Drug Administration (FDA) released a guidance for industry, researchers, and other stakeholders aimed at providing information on the use of DHTs for remote data collection as a recommended practice. DHTs are […]

The advent of Artificial Intelligence (AI) has heralded a new era in healthcare, promising to transform the development of medical products and enhance patient care. In a bid to harness AI’s potential while ensuring public health and ethical innovation, the U.S. Food and Drug Administration (FDA) has taken a significant step forward. The FDA’s Centers […]