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IVDR and MDR implementation seminar

If you are in the neighbourhood of Amsterdam this Wednesday 18 April, consider dropping by for our IVDR and MDR implementation seminar because there are still some seats left. IVDR is mentioned…

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Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an IVDR seminar

You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on…

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An unsurprising case of software qualification with an interesting twist

The unsurprising software qualification case that I wrote about earlier turns out to still have a little twist in the judgment that the European Court of Justice (CJEU) recently rendered in that…

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Happy New Medical Devices Year!

Happy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely. May your management be convinced that making and selling medical devices is actually core business…

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A wave of MDR and IVDR rollout coming our way

With the clock for the countdown to the end of transitional periods for the MDR and IVDR ticking away, everyone is of course very interested what the competent authorities are doing regarding…

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MDR and IVDR workshop at Advamed on 4 December

At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with…

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The notified body conundrum

In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for…

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EU MDR / IVDR Regulatory Cassandra

Sometimes you have days that you feel like Cassandra. I had a Cassandra moment after moderating the MDR panel at the Advamed MedTech Conference on 25 September. Cassandra was a lady from…

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IVDR, IVDs and mass extinction

More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD…

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