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Erik Vollebregt
Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Regulators using the joint plan will stay…
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Erik Vollebregt
This seminar addressed how to develop compliant medical software and how to prepare for increased scrutiny by the authorities. Speakers and their presentations: Robert Houtenbos, mHealth consultant How to design medical software…
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Erik Vollebregt
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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Erik Vollebregt
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint…
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Erik Vollebregt
I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain…