January 2020 - VigilanX

Europe’s Medical Device Directive (MDD)

Posted on 6. March 2020 by mactech

The Medical Device Regulation 2017/746 (MDR) defines PMS as: All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of […]

Why you need «VigilanX»!

Posted on 6. March 2020 by mactech

Sometimes though, despite your best intentions, situations do happen where a medical device you created is involved in a significant adverse event. In those cases, our job is to look at what happened and try to learn something from it so you can avoid repeating the same mistakes. To achieve this, you need a system […]