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Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…
Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…
Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…
Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…
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