This template is designed to outline the observations and results derived from the activities conducted as part of the Summative Evaluation Plan. It serves as a crucial component in assessing the safety and usability of the device, ultimately determining its readiness for commercialization. Aligned with industry standards, particularly IEC 62366-1:2015 + AMD1:2020 CSV and IEC/TR 62366-2:2016, this report provides a structured framework for presenting evidence regarding the device’s safety and usability. Through a detailed examination of the evaluation activities and their outcomes, stakeholders gain insight into the device’s performance in real-world scenarios.
Overall, it highlights key findings, including any observed safety concerns or usability issues, alongside recommendations for mitigation or improvement. By presenting this evidence, manufacturers can make informed decisions regarding the device’s readiness for market launch.
This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.
