Colleen Watson

Colleen Watson is Senior Director, Regulatory Affairs, at Thermo Fisher Scientific.

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    EU expert panels for high-risk devices - another level of review?


    The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both ...