If you missed one of our Newsletters, simply login to download it in PDF.
Latest release: July 2017
Cyber security for medical devices: An overview of applicable regulations
An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, Bluetooth and Ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being reported in the media.
It is therefore appropriate to examine the current regulatory position vis-à-vis connected medical devices.
Medical Device Single Audit Program
CE marking / European Medical Device Regulations
CE marking for IVD Devices
Quality Management System (QMS)