Quality system

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More on 3D printing (and biofabrication)

On 16 July I had the honor to give a lecture about Legal and Regulatory Aspects of 3D Printing (and biofabricaton) in the Focus on Life Sciences Summerschool program of University Medical…

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3D printing of custom medical devices under future EU law

Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical…

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Axon Seminar Medical Software & Apps 16 October 2013

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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New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices,…

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Improving implementation: the Code for Notified Bodies

It’s finally public: the Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC “Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of…

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Eudamed enters into full force

The European Database on Medical Devices (Eudamed) is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of…

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M&A in the medical devices sector: full seminar

On Wednesday 13 April I organised a seminar and realtime webinar at my firm about M&A in the medical devices sector, to discuss the legal and regulatory implications of an M&A project…

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Mind the reminder for Medical Devices and M&A seminar

I know, nobody likes reminders. But this one is for a good cause: our free seminar / webinar about M&A  in the medical devices sector this Wednesday 13 April in the afternoon. …

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M&A seminar: EU legal & regulatory aspects

Some time ago I wrote about issues often overlooked in medical devices M&A transactions. Because of the reactions to it I decided to organise a seminar at my law firm’s Amsterdam office…

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