CE marking

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Wearables Seminar Presentations

A lot of people turned up at this seminar on wearables and the regulatory, legal and commerical aspects. In case you were not able to make it, please find the presentations below:…

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The new Blue Guide is here

After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you…

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EU mHealth regulatory requirements and update: why the NO in innovation?

mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s…

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IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…

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CE certification of standalone software and apps seminar – the movie

Rather than streaming our last medical technology seminar on CE Certification of Standalone Software and Apps of 16 October in real time (big hassle and very prone to tech glitches we’ve found), we…

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ENVI vote results out: we have a draft legislative resolution

The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote…

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Surprise! Unannounced notified body audits Commission recommendation finally issued

While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been…

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Healthcare software enforcement alert

If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…

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"S" is for scope: does that include to 'enhance'?

The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its…

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