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Karin Verzijden
Onderstaand artikel is op 11 mei 2016 gepubliceerd in de nieuwsbrief van eGPO. ‘Tijdens het juridisch inloopspreekuur in de Zorginnovatiewinkel op 13 april werd aan mij (Sofie van der Meulen, Axon science based…
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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 EU ombudsman is urging the European Commission to reexamine allegations that Greek hospitals violated procurement laws to favor certain suppliers, saying the country has a history of flouting the law. The…
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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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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
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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Carine van den Brink
This seminar discussed the Unitary Patent, the Supplementary Protection Certificate (SPC’s) and the significance of patents. Speakers and their presentations: Karin Verzijden & Annemieke Kooy, Axon Lawyers Unitary Patent System and SPC’s…
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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…