Clik here to view.
FDA draft guidance on mobile medical applications
On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU...
View ArticleClik here to view.
Regulating Medical Software and nothing new on the Recast
Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak to many...
View ArticleClik here to view.
EU ENVI Parliamentary Committee resolution re Review : “learn the lessons of...
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...
View ArticleClik here to view.
Economist, why so pessimistic about open source medical devices software?
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...
View ArticleClik here to view.
FDA’s draft guidance on cybersecurity: nothing exciting but useful examples
These days I am more and more involved in medical devices software matters: interesting questions about modularisation, whether or not EHRs are medical devices in Europe and negotiation of systems...
View Article
