Medical devices

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Axon Seminar on Medical Devices Regulation Implementation

Please click on title for programme and invitation

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With Little Movement on Device Regs, EU States Turn to Joint Action Plan

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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UK MHRA issues guidance on device eIFU, but doubt is cast on its value

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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FDA draft guidance on mobile medical applications

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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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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FDA draft guidance on mobile medical applications

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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Devices at the DIA Euromeeting – drinks are on us!

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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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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Axon Seminar In Vitro Diagnostics Wednesday 12 September 2012

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…

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