The European Commission has issued a document that is highly relevant for manufacturers of reusable and resterilizable medical devices. You can find this document here. The background for issuing this… Read More
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More
Both, the Medical Devices Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 on Medical Devices (MDR) require manufacturers of medical devices to draw up a clinical evaluation for their devices. The overall aim… Read More
