The first draft of the updated ISO 14155:2011 is on its way and brings several important changes to the standard. More precise guidance is specified in many areas with alignment (where appropriate) to other GCP guidance documents.
The new updated international standard was conceived with input from regulators around the world with the much needed objective of reinforcing global harmonization of the conduct of clinical investigations for medical devices.
Presented by Danielle Giroud, convener for the expert group on clinical investigations TC 194 WG4 for the ISO 14155, this highly recommended webinar will provide you with the necessary guidance and insight on understanding the coming changes that will affect us all.
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