Document Templates

This table correlates the requirements from IEC 62366-1:2015 (organized by section) to their respective documents. Please note that the document titles in the “Fulfilled in Document” column are based on OpenRegulatory templates. You may have a different naming convention for […]

The Usability Evaluation Report provides a summary of the results from all usability evaluation activities, including both formative and summative assessments. Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.1.3 Information for Safety related to Usability

Classes IEC 62304:2006 Section Document Section A, B, C 5.8.1 (All) A, B, C 5.8.2 (All) A, B, C 5.8.3 (All) A, B, C 5.8.4 (All) B, C 5.8.5 (All) B, C 5.8.6 (All) A, B, C 5.8.7 (All) Overview

1. Overview This document provides details about the current medical device version, along with information on prior versions. Regulatory References: MDR Annex II Para. 1.2 This template is designed to guide the structure and content of your documentation. It is

This template is intended to demonstrate the structure. Avoid using Microsoft Word—this is designed to be used as an Excel or Sheets document. This list identifies technical issues (“bugs”) present in the current device that were deemed acceptable to remain

Regulatory References: IEC 62304, para. 5.3.6 [classes B, C] Other Relevant Documentation: SOP Software Development User and stakeholder requirements Design input and software specifications Software architecture documentation (…) 1. Evaluation Criteria Criteria Pass / Fail The software architecture aligns with

Table of Compliance IEC 62304:2006 Reference Table Classes IEC 62304:2006 Section Document Section A, B, C 5.1.2 4 A, B, C 5.2.1 4 A, B, C 5.2.4 3, 7, 10 A, B, C 5.2.5 4 A, B, C 5.2.6 5

The SR ID refers to the unique identifier of the software requirement that this test is designed to validate. It’s important to note that this document isn’t technically a “plan” since it includes test results (the “Actual” and “Pass?” columns).

ISO 13485:2016 Section Document Section 7.3.2 (All) Classes IEC 62304:2006 Section Document Section A, B, C 5.1.8 (All) 1. Overview This checklist is intended to ensure that user needs are complete and consistent. Key documents involved: User Needs (Document ID)

Disclaimer This template is designed for companies developing devices that incorporate machine learning algorithms. Why is this template necessary? Due to the “black box” nature of many ML algorithms, their functionalities cannot typically be verified in the same way traditional