ISO 14155:2026 – Risk Management for Clinical Investigations

During this live Q&A session, Danielle Giroud answered questions from participants regarding the implementation of ISO 14155:2026, with a particular focus on risk management throughout clinical investigations.

The discussion covered key concepts introduced in the revised standard, practical considerations for applying risk management in clinical studies, and common challenges encountered by sponsors, manufacturers, CROs, and investigators. Participants also had the opportunity to ask questions about real-life scenarios and receive practical guidance based on current regulatory expectations.

This recording provides valuable insights for professionals involved in the planning, conduct, oversight, or evaluation of clinical investigations involving medical devices.