You are looking for

The European Parliament adopted another report this week focused on safety in healthcare highlighting the huge costs to healthcare systems, not to mention the enormous costs to patients, for preventable injuries, complications and infections.  While I admire the Parliament’s attention to these issues, it is still clear that many of the calls for improved monitoring […]

In my article in the newsletter of last August, I told you about the standard rehabilitation support I receive as outpatient of spinal cord injury (SCI), and how I have had to work for access to more personalised treatment, which has brought to where I am today. However, be that as it may, my current state of rehabilitation remains insufficient and my search for better alternatives continues. 

Two years ago in our annual report on the medtech sector, Pulse of the industry, we warned that the sector was facing a perfect storm, caused by a general shift toward value-based care, growing regulatory pressure in the US and limited resources as a result of a global downturn. Those events came to pass, with the added complication of tougher new regulatory issues in Europe. It was time, we felt, in this year’s report to see how the sector is weathering the storm.

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.