The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...
Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...
The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...
Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...
A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR. When a nonconformance is identified, two things should be done ...
An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...
The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, ...
The application of AI in telehealth to allow doctors to make real-time, data-driven rich choices is a key component in generating a better patient experience and improved health outcomes. Artificial ...
Infographics can propel MedTech research and campaigns and enhance the user experience. Here Fabricio Pamplona, co-founder of online infographic maker for scientists Mind the Graph, explores the power ...
Rejected by leading customers Physicians as customers/intermediary complicates adoption pathways. Emerges in niche/small markets Sophisticated epidemiology and real-world data allow larger initial ...
The use of Radio-Frequency Identification (RFID) technology in healthcare, particularly within closed-loop systems, presents complexities, including potential limitations on interoperability that can ...