Discover the Italian Guidelines on Safety and Performance of Veterinary Devices, outlining key requirements for manufacturers to ensure efficacy
Explore the transformative impact of Artificial Intelligence in the medical device field, from disease detection to personalized treatment.
Learn about the key steps in medical device validation, including process validation phases and regulatory aspects.
Get insights on the differences and similarities in IVD requirements between the US and EU markets.
Learn about the qualification process, classification rules, and standards that apply. Stay compliant with medical device regulations.
Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and.
New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.
Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.
The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.
The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.
