Home » Authors » Romaric Marcilly, Sabrina Bras da Costa, Cesar Boog, Marie-Catherine Beuscart-Zephir, Julien de Jonckheere, Sylvia Pelayo

Romaric Marcilly, Sabrina Bras da Costa, Cesar Boog, Marie-Catherine Beuscart-Zephir, Julien de Jonckheere, Sylvia Pelayo

Public reference bibliography and cataloged PDF materials authored or published by Romaric Marcilly, Sabrina Bras da Costa, Cesar Boog, Marie-Catherine Beuscart-Zephir, Julien de Jonckheere, Sylvia Pelayo.

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Impact of the context of use analysis for the extension of an existing medical device: an analgesia monitor case study.

Year: 2013 • Source: hal.science • Listed PDF

The EU revised Medical Device Directive introduces a major change in the CE marking of medical devices (MD) aiming at improving their safety. Manufacturers must now comply with an "ergonomics" essential requirement to pr...