Here, you will find helpful information on different regulatory affairs related topics in the medical device field.
Understanding the new EU AI Act: Legislative Background: The European Parliament and the Council of the European Union are the main bodies involved in the legislative process. The act is based on Articles 16 and 114 of the Treaty on the Functioning of the European...
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...
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...
🌍 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...
An In-Depth Guide for Manufacturers Post-market surveillance (PMS) is a critical regulatory requirement for medical devices and in vitro diagnostic devices within the European Union. The EU MDR 2017/745 and IVDR 2017/746 lay down specific guidelines for post-market surveillance to ensure ongoing safety, performance, and...
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...
In the medical device industry, a Regulatory Affairs Job, such as a Regulatory Affairs Specialist or Regulatory Affairs Manager, plays a pivotal role in guiding a medical device from its development phase to its sale in the market. These Regulatory Affairs professionals ensure that medical...