Solution Archives

1. Your actual QMS?

Posted on 13. February 2020 by mactech

How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company–usually document control. Maybe you are using Excel or […]

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 […]