medicaldeviceslegal

Team NB FAQ on EN62304 standard for software lifecycle processes

Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on an FAQ document shedding more light on how this standard works, as to enable companies to conduct more productive discussions with their notified […]

medicaldeviceslegal

The IVD regulation proposal in a nutshell

With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go. As a starting point, […]

Axon news

Presentations Corporate Law Seminar

Axon Seminar Corporate LawPresentations can be downloaded by clicking on the titles:New Dutch company law, Introduction of the Flex BV by Ernst Rozelaar, Schut Van Os Civil NotariesVenture Capital & Corporate Governance in practice by Harrold van …

Axon news

European Regulation Looms Over Mobile Health

The mHealth Regulatory Coalition, an industry group that has been active in engaging FDA on evolving mobile health policies, is now extending its efforts to Europe as the European Union and several member countries are planning new regulations read mo…

medicaldeviceslegal

eHealth and mHealth at the DIA Euromeeting

I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology Assessment and Science of DG SANCO of the European Commission and Mrs Marianne Fournier of Voisin Consulting. In a lively session we took […]