---
title: "IEC 62304 Compliance Checklist"
type: white-paper
publisher: Ketryx
source: "https://www.ketryx.com/assets/iec-62304-compliance-checklist"
content: text extracted from PDF (layout/tables/figures not preserved)
---

# IEC 62304 Compliance Checklist

*Source: [https://www.ketryx.com/assets/iec-62304-compliance-checklist](https://www.ketryx.com/assets/iec-62304-compliance-checklist)*

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INTRODUCTION Creating IEC 62304-compliant software is a challenging, time-consuming task. For companies first transitioning into building IEC 62304-compliant software, the challenge might seem too big. Luckily, companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps. Q Do you have a Quality Management System (QMS)?

QMS is a set of rules and procedures used to manged quality and regulatory processes. If you don’t have a QMS you will need to get one to comply with IEC 62304 and FDA regulations in CFR 21 Part 820. If you have a QMS you have already noticed that existing QMSs were never built for software. They consist of hardware QMS documents that are modified to accommodate software development. They have not been built for software and that’s why they don’t work. If you need a software QMS, try Ketryx’s QMS, built by developers, for developers. Q Have you evaluated your quality management processes? Have you already established most QMS processes, but you haven’t documented them? Do you have a QMS, but you’re not sure it is software-ready? Use the Ketryx Quality Evaluation Form to find out.

IEC 62304 Compliance Checklist Activity IEC 62304 Section Covered by Existing Procedure Actions to be taken No Yes (Mention reference) Plan software development 5.1 Analyze software requirements 5.2 Design software architecture 5.3 Design detailed software 5.4 Implement and verify software units 5.5 Integrate software modules and test integration 5.6 Test software system 5.7 Software Release 5.8 Establish software maintenance plan 6.1 Problem and modification analysis 6.2 Modification implementation 6.3

Analyze software contributing to hazardous situations 7.1 Use risk control measures 7.2 Verify risk control measures 7.3 Manage risk of software changes 7.4 Identify configuration 8.1 Control change 8.2 Account for configuration status 8.3 Create process to resolve software problems 9