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.

WMDO’s 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 ISO 14155:2020 covering all sections from  ethics considerations, to clinical investigation planning, conduct and close out, as well as Sponsor and Investigator responsibilities.

“ISO 14155:2020 - In Depth Review” consists of 7 distinct courses and jam-packed with over 4 hours of valuable, state-of-the-art information for professionals who can’t afford not to be current.

Course 1. Scope
Course 2. Ethics Considerations
Course 3. Clinical Investigation Planning
Course 4. Clinical Investigation Conduct
Course 5. Clinical Investigation Close Out
Course 6. Responsibilities of Sponsor
Course 7. Responsibilities of Principal Investigator

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
• Understand how risk management is applied to all aspects of medical device clinical investigations
• Comprehend the different types of clinical investigations, study designs and how ISO 14155’s requirements apply
• Adapt their procedures to the new requirements compared to the ISO 14155 2011 version.