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 for compliance

Erik Vollebregt, Axon Lawyers Developments in regulation and enforcement

Hans van Dulmen, DRS Practicalities of CE technical file and quality system


Navigate through our knowledgebase

Related articles

Article

Verelendung is a process, people!

Over the summer holidays I (and perhaps some other people too) were in burning anticipation about announced measures to be adopted to deal with the MDR slowly moving to a big crunch…

Read more

Article

The Blue Guide 2022 update – new elements regarding applicability of EU law on products

As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post…

Read more

Article

The Blue Guide 2022 update – new elements regarding applicability of EU law on products

As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post follows up in detail on the changes in Chapter 2. Chapter 2 of the Blue Guide explains when EU law on products applies, […]