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ISO 14155 Appendix A.14 g) requires a list of foreseeable AEs and anticipated ADEs, together with their likely incidence, mitigation or treatment. I'd like to understand the best ways to generate the list of AEs to be included in the IB for a fist-in-human clinical study of a medical device. Is it simply the residual risks from the risk analysis? And how have you communicated the likely incidence when the device hasn't been used clinically? Thank you!