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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
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…
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Erik Vollebregt
Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP…
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Erik Vollebregt
You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at…
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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
While everybody is running around about the MDR and IVD regulations proposals another storm is brewing in the wings: unannounced audits, which I announced earlier. Currently notified bodies “may” do unannounced audits…
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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…