You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information, we mean technical documentation. All those documents you have to have it in one place, organized, before providing the final… 

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few… 

CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know…