This is an online, in person training course scheduled for 18th of May 2023, (09.00 – 16.00) consisting of a 1 day course and a final assessment quiz.
The intent of the ISO14155:2020 standard training program is to provide crucial guidance and support to any party involved in the conduct of Clinical Investigations with human participants – Sponsors (including monitors) and investigators, but also includes ethic committees, regulatory authorities and notified bodies assessing the conformity assessment of medical devices.
The new version of the ISO standard aligns with the European Medical Device Regulation (EU MDR 2017.745), the ICH E6 (R2) guidelines n Good Clinical Practice and FDA guidance documents with a focus on medical devices. The updates ensures the standard is relevant and maintain acceptance by the global medical device industry. The focus of the updates is on the increasing demand to demonstrate safety and data reliability.