First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and the IVDR. The summer is a bit more quiet so you can expect more content again. Intermezzo on software under MDR and GDPR […]
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably […]
In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number of other documents, after it was adopted at the meeting n Brussels 12-14 November 2013. People that commented on the document will remember that the […]
Rather than streaming our last medical technology seminar on CE Certification of Standalone Software and Apps of 16 October in real time (big hassle and very prone to tech glitches we’ve found), we decided to record a video of it instead, and post that on my firm’s brand new Youtube Channel (watch that space for more […]