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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
The UK Medicines and Healthcare products Regulatory Agency has issued guidance on how medical devices manufacturers can provide an electronic format of their instructions for use (eIFU). However, the guidance has come…
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Carine van den Brink
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
The DIA Euromeeting is quickly becoming a more an more interesting event for the medical devices community, as the DIA has been working on getting a full devices theme in place for…
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Erik Vollebregt
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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Carine van den Brink
Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…