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Erik Vollebregt
As announced, the IMDRF is on the case for software, which shows how important this subject is becoming in the medical devices field. I notice this everyday in my medical devices practice,…
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Erik Vollebregt
The European Article 29 Working Party has just released its opinion 02-2013 on apps on smart devices. This detailed opinion provides very useful and detailed guidance for companies developing and distributing healthcare…
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Erik Vollebregt
Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a…
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Erik Vollebregt
And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the Combined…