Risiken und Nebenwirkungen der Integration medizinischer Software in klinische IT-Strukturen – Erlanger Memorandum [Software as a medical device – side effects when applying the new European regulation on medical devices for IT products]

[english] European medical device regulations have been altered to cover pure software applications as well. They now may be classified as a medical device if used for medical diagnostics and/or medical treatment. Slowly, these regulations are being implemented into national law of the EEC member st...

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Bibliographic Details
Main Authors: Kaiser, J., Gassner, U.M., Reng, M., Prokosch, H.U., Bürkle, T.
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2012-12-01
Series:GMS Medizinische Informatik, Biometrie und Epidemiologie
Online Access:http://www.egms.de/static/en/journals/mibe/2012-8/mibe000127.shtml