Despite the contentious nature of the negotiations, as well as criticism levelled at some of the new provisions, analysts appear to agree that the USMCA represents an upgrade — albeit a modest one — over NAFTA for all parties included.
Clinical research professionals often turn to healthcare professionals to critically assess the complex prioritization and planning of clinical research and to act as surrogates for the patient perspective.
Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution.
In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?
China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.
In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.
Three decades ago when I entered the profession of clinical research, our workplace equipment extended to typewriters, white-out, mimeographs, hand-written documents, rubber erasers, pens, label makers, and fax and copy machines. Rows of massive, locked, fire-proof filing cabinets storing millions of papers for a nationally funded research program lined record rooms, hallways, and every spare corner of the offices. Most of us felt rewarded when we could use a typewriter with a correction key despite one’s typing skills being firmly judged by the illegible mistakes in the carbon copies.
There exist far fewer pediatric devices than adult devices on the market, meaning one of the most vulnerable patient populations also is one of the most underserved.
The U.S. gastrointestinal (GI) endoscopic device market is increasingly focusing on specialized procedures, propelling the launch of innovative devices that address unmet medical needs and drive overall market growth.
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