Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this...

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European...

In an increasingly impacted environment influenced by emerging technologies such as robotics and artificial intelligence, such technologies will also impact the use and control of medical devices. Regulation of such medical devices can adopt regulatory techniques which apply in the field of...

In the past two years, the FDA has issued several important new guidances that radically altered the rules for medical device manufacturers on the inter-related topics of biocompatibility, reprocessing, and sterilization. This master’s thesis discusses various aspects of these policy changes...