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Erik Vollebregt
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 integration agreements…
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Erik Vollebregt
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…
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Erik Vollebregt
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…
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Erik Vollebregt
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…
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Erik Vollebregt
On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth…