Author: Michael Galiker

Understanding EUDAMED EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. Its primary purpose is to enhance market transparency and oversight in the medical device field by providing a comprehensive repository of information on medical devices and...

An In-Depth Guide to Understanding the Advantages for Regulatory Affairs Professionals In the fast-paced world of regulatory affairs within the global medical device industry, staying up to date with complex and ever-changing regulations is a huge challenge. Amidst this complexity, a powerful new technology has emerged...

🌍 Stay Ahead in the Medical Device World! 🌍 Navigating the intricate landscape of EU medical device regulations can be challenging. Whether you're delving into the nuances of MDR, IVDR, or exploring the frontier of AI in medical devices, we've got you covered. ✨ Why Subscribe to...

What is MDCG? The MDCG ensures that regulatory authorities in the European Union member states have a forum for coordinating their efforts and sharing best practices related to medical device regulations. This includes the implementation and application of the MDR and the IVDR. This group also...