European CE

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Economist, Why so Pessimistic about Open Source Medical Devices Software?

medicaldeviceslegal | Erik Vollebregt | June 11, 2012

I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing all the benefits of medical devices software that is developed using open source models, and there are many...The article concludes however that open source has no place in the current regulatory environment and points only to FDA regulation for that conclusion. Read More »