IEC 62304 vs US FDA Software documentation requirement
Oct 2, 2023 · Hi, With the recent US FDA release of the guidance "Content of Premarket Submission for Device Software Functions", does anyone know or have an updated version of …
IEC 62304 - Functional and performance requirements for SOUP …
Jul 22, 2020 · Hello All, So the 62304 requires us to: 5.3.3) Specify functional and performance requirements of SOUP item If a SOFTWARE ITEM is identified as SOUP, the …
Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304
Jun 7, 2020 · Hello all, I'm having a little bit of trouble reconciling the flow between ISO 14971 and IEC 62304. My current approach is as follows: 1) Perform hazard analysis per 14971 - this …
Software validation with IEC 60601-1, 61508-3 or 62304?
Feb 12, 2024 · IEC 60601-1 is for medical electrical equipment. In contrast, IEC 61508-3 is for safety-related systems that are not medical equipment (i.e., not within the scope of the 60601 …
Practical definition of IEC62304 Software Items and Software Units
Jul 13, 2010 · In IEC62304, it is left to the manufacturer to provide the definition and granularity of Software Items and Software Units. Can anyone offer guidance or share industry experience …
IEC62304: Creating Software System Tests for legacy software
Jan 30, 2025 · E B Scope of Unit Testing for a Class C Software System BuckeyeBurro Dec 9, 2024 IEC 62304 - Medical Device Software Life Cycle Processes Replies 5 Views 671 Dec 10, …
Changing software classification via software - IEC 62304
May 3, 2018 · I have a question about the software classification as per clause 4.3 in edition 1.1. (2015 version) of 62304. In clause 4.3 the following statement is made: For a SOFTWARE …
IEC 62304 Class C Unit definition documentation
May 21, 2025 · The Proxy, written in about 2000 lines of code, needs to be documented efficiently according to IEC 62304. We have the following questions: Single Unit Definition: Given the …
EN 62304:2006/AC:2008 vs IEC 62304:2006/Amd 1:2015
Feb 15, 2023 · Since we have IEC 62304:2006/Amd 1:2015, how does it correspond to EN standard which is already obligatory (EN 62304:2006/AC:2008)? The mentioned IEC standard …
Class B IEC 62304 - 5.4 Software Detailed Design
Apr 14, 2023 · Hello, Our medical device software is a class B according to IEC 62304. clause 5.4.1 requires us to document our "subdivision our software into software...