Have you ever been in a situation where during an audit, the auditor asks you to prove that your Quality Management System software is validated? You might think, “But I bought it already set up, why do I need to validate Read more… The post Validation of...
The EU Battery Regulation 2023/1542 will start to be implemented with few deadlines that are coming. On this blog post, we will summarize the situation and welcome you to watch the Podcast Episode done with Erik Vollebregt. The post EU Battery Regulation 2023/1542:...
The UDI is one of the new innovation that comes with the new Medical Device Regulation MDR 2017/745 and also the IVDR 2017/746. On this article I tell you what you need to understand how to implement this new tool. The post UDI Beginners Guide: Unique Device...
Post-Martketing Surveillance is an activity that your company should do at a regular frequency. So let's learn how this should be done the right way. The post What is the Post-Market Surveillance for Medical Devices? appeared first on Medical Device Regulation and ISO...
The United States House Committee on Ways & Means (the “Ways & Means Committee”) advanced the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) (the “Bill”) out of committee on June 27, 2024. The Bill allows...
