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