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Axon Seminar In Vitro Diagnostics Wednesday 12 September 2012

Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…
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EU court decides another borderline case regarding "pharmacological effect"

Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar. The judgment immediately brought one of my favorite Yogi Berra quotes to mind: “You’ve got…
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In Vitro Diagnostics seminar at Axon Lawyers on 12 September

Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with…
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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…
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Everything you always wanted to know about stand alone software, but were afraid to ask

I hope you won’t mind me imposing on you with some more self promotion – it’s for your own good as this is about saving you money, both in the short run…
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EU court rules on no-fault liability for medical services with medical devices

The judgment in the Centre hospitalier universitaire de Besançon v Thomas Dutrueux, Caisse primaire d’assurance maladie du Jura case that I wrote about earlier has been handed down by the EU Court on…
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More on mobile medical apps, and on clinical decision support systems

I have been running around a lot lately doing presentations on conferences about medical devices and software, so I though it would be useful to give you a round-up on that subject….
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Something new at Eucomed's MedTech Forum (also about the Recast)

Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011. At the end of conference I did learn something…
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Critical analysis of the European Society of Cardiologists' report on medical devices problems, and its proposals for reform

Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European…
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