Op de opiniepagina van het FD van 22 juni jl.
Flink aantal medische apps is ‘illegaal’Een flink aantal medische apps, kleine computerprogramma’s voor telefoon of tabletcomputer, is illegaal. lees meer …
Flink aantal medische apps is ‘illegaal’Een flink aantal medische apps, kleine computerprogramma’s voor telefoon of tabletcomputer, is illegaal. lees meer …
Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time the final text was not out because the EU Parliament still had to vote on it. Now it has and the adopted resolution does […]
I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing all the benefits of medical devices software that is developed using open source models, and there are many. For example, security of […]
InleidingEr komt meer en meer software op de markt die in een klinische setting wordt gebruikt. Tot voor kort vond met medische software in klinische setting vooral op PACS-systemen, op netwerken lees meer …
The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The other two are C-109/12 Lycocentre and C-308/11 Chemische Fabrik Kreussler, with respect to the latter see also here. The other two are more […]
Reparatie medische apparatuurNu ziekenhuisbudgetten meer en meer onder druk komen te staan, merk ik in mijn praktijk dat ziekenhuizen meer uitwijken naar andere partijen dan de OEM voor reparaties die na verloop van de garantietijd moeten plaatsvinden…
Implanting Quality and rooting out riskFirst it was burst breast implants and then disintegrating hipimplants. After making headlines around the world, finger-pointing ensued, with both regulatory authorities and manufacturers coming under read more …
The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of the Review of the medical devices directives, still scheduled for the end of Q2 2012 as far as I know. At its meeting […]
Presentations can be downloaded by clicking on the titles:ATMPs by Eliane Schutte, SignifixLatest developments in biotech patents by Carine van den Brink, AxonCell-based therapies legal & regulatory by Alex Denoon, Lawford Davies Denoon and Erik V…
Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to safeguard the credibility of the EU medical devices vigilance system (which are conveniently summarised in his speech of 9 Febuary 2012): the Dutch […]