EU MDR

Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen.…

The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in…

The whole point of medical devices is to improve patient safety and patient quality of life. That's it, that's the gist. To…

MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature searches within the European medical device regulatory framework.…

The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions…

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The…

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of…

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex.…