notified body

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Axon Seminar Clinical Trial Data 9 April 2014

This seminar addressed the review of the regulatory requirements for clinical trials. Speakers and their presentations: Joris Bannenberg, Factory-CRO Developments in Clinical Trials for Medical Devices Erik Vollebregt, Axon Lawyers Clinical Trial…

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Happy Holidays, and an exciting and innovative New Year to you – and a correction

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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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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In the mean time… joint immediate action plan, unannounced audits and other things over the summer

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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ENVI's 29 may debate on medical devices

The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very…

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ENVI's amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…

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Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

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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Axon Seminar Medical Devices Wednesday 14 November 2012

The seminar addresses the changes in the new medical devices regulation compared to current legislation. Speakers and their presentations: Sabine Hoekstra-Van den Bosch, Philips Healthcare Recast of Medical Device Directives Luc Sterkman,…

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"U" is for unannounced audits – what's up with those?

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…

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