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Technical-File-Template-Medical-Device

Summative Evaluation Plan Template

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Summative-Evaluation-Plan-Template

This template is designed to outline strategies for identifying and mitigating user-related errors, thereby reducing use-associated risks. It serves as a proactive approach to ensuring the safety and effectiveness of the device by simulating actual use scenarios with the intended user population. Aligned with industry standards, specifically IEC 62366-1:2015 + AMD1:2020 CSV and IEC/TR 62366-2:2016, summative evaluation plan adheres to best practices in usability engineering. It aims to validate that the users defined in the Use Specification can effectively and safely operate the device.

The plan delineates a structured approach to conducting usability testing, including the selection of appropriate user populations, creation of realistic usage scenarios, and evaluation of user interactions with the device. By systematically identifying and addressing potential user-related errors, manufacturers can enhance the device’s usability and minimize associated risks.

This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.

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