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Karin Verzijden
Do bugs have a place on your dinner plate other than the fly that lands on it or the caterpillar that accidently ended up in your dish, as it happened to live…
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Erik Vollebregt
In a previous blog I have addressed the genetic testing amendment to the IVD regulation proposal and have provided argumentation why this proposal is outside the scope of the legislative competence of…
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Erik Vollebregt
I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my…
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Karin Verzijden
In one of our previous blog posts this year, we provided a summary of the Commission’s proposal for a new Regulation on Novel Foods. We reported that the proposal contained an open…
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Erik Vollebregt
It’s been a matter of a lot of speculation where the devices policy and HTA policy will finally end up in the European Commission. When the Commission-elect was presented, one of the…
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Erik Vollebregt
Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices…
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Erik Vollebregt
I gave a presentation on current and future developments in UDI at the RAPS 2014 conference in Austin last week, sitting on a panel on global developments in UDI with presentations on…
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Karin Verzijden
The use of nutrition and health claims is gaining wider application in the food industry. At the same time companies in the horticultural sector focus their marketing more and more at end…
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Erik Vollebregt
If you’ve missed the 2014 RAPS conference you’ve missed out on the opportunity to learn a lot about unannounced audits by notified bodies. Not only were the notified bodies themselves out and…