Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been [...]
The short answer is, yes, it can be. MDR compliance may not have been [...]
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are [...]
Being a medical device manufacturer involves more than the actual manufacturing of the medical [...]
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk [...]
Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks [...]
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since [...]
By now, most of us have struggled through at least one successful submission for [...]
You know what is common in all countries? No matter the geographical position, the [...]
We all know and love (ahem) the EU MDR (2017/745). And although it is [...]
The medical device industry is fueled by innovation. Research and development are the blood [...]