---
title: "Standards and Regulations for Software Used in Medical Devices"
description: "Learn how IEC 62304, IEC 82304 and ISO 13485 fit together and which standards matter for your medical device software."
url: https://qbdgroup.com/en/downloads/standards-and-regulations-for-software-used-in-medical-devices
type: "White paper"
language: en
published: 2024-11-12
publisher: "QbD Group"
citation: "QbD Group, \"Standards and Regulations for Software Used in Medical Devices\", https://qbdgroup.com/en/downloads/standards-and-regulations-for-software-used-in-medical-devices"
---
# Standards and Regulations for Software Used in Medical Devices
> Learn how IEC 62304, IEC 82304 and ISO 13485 fit together and which standards matter for your medical device software.

Medical device software comes with a complex web of standards, regulations and terminology. Which requirements apply to your software? And how do IEC 62304, IEC 82304 and ISO 13485 fit together?

This white paper helps you navigate the regulatory landscape and understand which standards matter for your medical device software and why.

## About This White Paper

Developing software for medical devices means navigating a landscape where different regulations, standards and definitions overlap. The requirements can vary depending on your market, your intended use and, crucially, whether your software is standalone or embedded in a medical device.

This white paper brings structure to that complexity. It explores the regulatory framework for software used in medical devices, clarifies key terminology and takes a closer look at the respective roles of IEC 62304 and IEC 82304. While IEC 62304 addresses software life cycle processes and verification, IEC 82304 adds the validation perspective for standalone health software.

It also examines how both standards contribute to ISO 13485, helping you see the bigger picture rather than treating individual standards as isolated compliance requirements.

## Key Takeaways

- **Understand Which Rules Apply to Your Software.** Get a clearer view of the regulatory landscape for medical device software, including key EU and US regulations and the standards that support compliance.

- **Navigate Medical Device Software Terminology.** Understand the distinctions between health software, Medical Device Software (MDSW) and Software as a Medical Device (SaMD), and why correctly defining your product matters before determining which requirements apply.

- **Distinguish Standalone from Embedded Software.** Learn why the relationship between software and the overall medical device affects how verification and validation should be approached.

- **Understand IEC 62304 vs. IEC 82304.** Discover the complementary roles of both standards: IEC 62304 focuses on software used in medical devices and its verification, while IEC 82304 addresses standalone health software with an additional focus on validation and intended use.

- **See How Software Standards Connect to ISO 13485.** Explore how IEC 62304 and IEC 82304 contribute to areas such as product realization, risk management, software development, maintenance, configuration management and post-market activities within the broader ISO 13485 quality framework.

- **Avoid Treating Individual Standards in Isolation.** Understand why implementing IEC 62304 or IEC 82304 alone is not enough to comply with ISO 13485, and how the different standards need to be viewed as interconnected pieces of the wider quality and regulatory framework.
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Source: https://qbdgroup.com/en/downloads/standards-and-regulations-for-software-used-in-medical-devices — © QbD Group. Quote freely with attribution and a link back.