The European Union (EU) has established medical device regulations to protect the public from potentially unsafe or ineffective products

The EU regulation 2017/745 (MDR) and 2017/746 (IVDR) for medical devices provide detailed protocols for the rigorous and comprehensive...

Technical Documentation Once we have mapped the requirements, understood the classification, coordinated expectations with the notified...

The new EU regulations (MDR & IVDR) are here – hurry up to follow and adapt to the changes! According to The European Commission Q&A...