Neil Dahiya

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

Classes IEC 62304:2006 Section Document Section A, B, C 6.2.3 2 A, B, C 6.2.4 2 A, B, C 6.2.5 2 A, B, C 6.3.1 3 A, B, C 6.3.2 3 A, B, C 7.4.1 2 B, C 7.4.2 2

Classes IEC 62304:2006 Section Document Section A, B, C 5.2.6 (All) ISO 13485:2016 Section Document Section 7.3.3 (All) 7.3.5 (All) 1. Overview This checklist is designed to verify and review software requirements prior to their implementation. Like all regulatory documentation,

1. General Overview This SOP outlines the process for supporting the initial integration and updates of our medical devices into customers’ IT systems. It also includes user management and training. The purpose of following this procedure is to ensure our

The Guidelines for Data Acquisition outline the types of data that are collected and annotated (prepared) for machine learning model development. While the general requirements for data acquisition can be broadly defined, the subset of data used for annotations needs

Classes IEC 62304:2006 Section Document Section B, C 5.6.8 (All) A, B, C 6.2.1.3 1 A, B, C 6.2.2 (All) A, B, C 9.1 1 A, B, C 9.2 2 A, B, C 9.3 3 A, B, C 9.5 1

This roadmap outlines the process for creating the TechDoc file, organized by “Design Phase”. Each document has an assigned author who is responsible for its creation. Proceed through each phase step-by-step, although documents within a phase can be completed in

This document pertains to your product, and it should be linked to it for clarity. A straightforward approach is to place all product-related documents into a folder within your Quality Management System (QMS) to maintain a clear association. Alternatively, you