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.
Focus on the important updates of the publishes Guideline on Computerized Systems and Electronic Data for Clinical Trials.
MHRA's top findings per chapter and E-book for download
Pharmacovigilance System Master File (PSMF), describes the details of the pharmacovigilance system, focusing on the Quality Management System (QMS).
