Program Description

The ISO 14155 standard provides crucial guidance and support to any party involved in a clinical investigation -primarily to Sponsors (including monitors) and investigators, but also ethics committees, regulatory authorities and notified bodies implicated in the conformity assessment of medical devices.

The latest revision brings significant changes and improvements throughout the majority of areas on clinical research with medical devices covered within the document. This course provides not only a description of the contents of the document but a comprehensive and practical guidance on how to implement the requirements - including many examples.

Although the latest version of the standard has yet to be officially released by the ISO administration, WMDO clinical expert and TC 194 WG4 convener for the ISO 14155, Danielle Giroud has compiled for you this revealingly in depth and up to date review covering everything from the scope of the newly revised ISO 14155 and ethics considerations, to clinical investigation planning, conduct and close out, as well as Sponsor and Investigator responsibilities.

Upon completion of this course, trainees will be able to correctly and successfully:

• Comprehend and apply the requirements of the ISO 14155 as a GCP guidance specifically for medical device clinical investigations from start to finish.