IEC 62304 Templates

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

Purpose: The Guidelines for Data Annotation detail how datasets should be annotated by medical experts to apply the labels necessary for training a machine learning model. They establish a standardized annotation style, defining both the accuracy and format of annotations.

IEC 62304 requires the documentation of SOUP, which stands for Software of Unknown Provenance. In simpler terms, these are third-party libraries integrated into your code, often listed in files such as requirements.txt or Gemfile. Classes IEC 62304:2006 Section Document Section

Regulation / Guidance Document Section Medical Device Regulation, Annex IXChapter II Section 4.10 All MDCG Guidance Document 2020-03 All Overview: This record is designed for documenting the evaluation of routine change requests as part of the company’s change management process.

1. Regulatory References Applicable Regulations: IEC 62304, paras. 5.3.1 and 5.3.2 [classes B, C] Related Documentation: SOP Software Development User and stakeholder requirements Design input and software specifications (…) 2. Software Systems In line with DIN EN 62304, our software

Applicable Regulations Document Section IEC 62304, Chapter 9 All Overview This record serves to document the assessment and execution of all bug fixes following the company’s change management procedure. Bug Fix Documentation Evaluation Criteria Bug ID #B01 #B02 (…) Description