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Erik Vollebregt
ENVI’s amendments, following those of IMCO have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…
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Erik Vollebregt
That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we…
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Erik Vollebregt
And now for something completely different from all the discussion about future rules and where they may take us: the RAPS Dutch/Flanders chapter has been active in defining a list of EU…
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Erik Vollebregt
Yet another post! Apologies, I am very productive these days. A lot is happening and I am just trying to keep track because the moment is NOW if we don’t want to…
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Erik Vollebregt
I am very pleased to publish a guest blog by Annet Muestege, director and co-founder of Applied Clinical Services BV., which dives into the clinical aspects of the DRB report proposal in…
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Erik Vollebregt
Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on…
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Erik Vollebregt
Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for rapporteur Liese’s amendments for the IVD regulation proposal to also be published….
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Erik Vollebregt
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary…
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Erik Vollebregt
After the GHTF had been decommissioned – much to the disappointment of many – the IMDRF had big shoes to fill and everybody is watching if they manage. The outcome statement of…