Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.
2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.
The EU is the first to try to finally regulate AI as part of its digital strategy. The EU AI Act should pass into law in early 2024.
New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.
Why is it important to test glove integrity in isolators or rabs and when should it be done? What norms and regulations apply to glove integrity.
Cannabis sativa is a dioecious plant that is widely distributed in areas with a temperate climate. The plant has three main varieties, each with its.
Explore the benefits and considerations of implementing an Electronic Laboratory Notebook (ELN) to enhance laboratory data management.
Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.
At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right.
The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.
